CERTIFICATE TO FOREIGN GOVERNMENT

Transcription

1 tr ~~ _,~,v.k\"l<'l;s ~ ~';::jt "';,, f(lt},"'" DEPARTMENT OF HEALTH & HUMAN SERVICES PubHc Health Service In order to allow the importation of United States products into foreign countries, the U.S. Food and Drug Administration (FDA) certifies the following information concerning the product(s) to be exported listed below: Name of Product(s) See Attached List (11 Pages) Name of Manufacturer/Distributor, Address See Attached List (One Page) The product(s) described above (and the manufacturing/distribution site(s) which produces/distributes it) is subject to the jurisdiction of the FDA under the Federal Food, Drug, and Cosmetic Act. It is certified that the above product(s) may be marketed in, and legally exported from, the United States of America at this time. The manufacturing plant(s) in which the product(s) is produced is subject to periodic inspections. The last such inspection showed that the plant(s), at that time, appeared to be in substantial compliance with current good manufacturing practice requirements for the product(s) listed above. CERTIFICATE TO FOREIGN GOVERNMENT ~?Y:~arv- Robin W. Newman MSN EdD CPNP Director Office of Compliance Center for Devices and Radiological Health U.S., DHHS This certificate is valid from September 12, 2017 to September 11, 2019.

2 ( J "'' Jtp'k"<, DEPARTMENT ~ ~ '.,;~<40 OP HEAL TH & HUMA N SERVICES Silver Spnng, MD Certificate to Foreign Government - Name of Manufacturer/Distributor Attachment Page 1 of 1 Name of Owner Operator SUNTECH MEDICAL, INC. 507 AIRPORT BOULEVARD SUITE 11 7 Morrisville. NC USA Name of Manufacturer/Distributor Legal Manufacturer/Distributor SUNTECH MEDICAL. INC. 507 AIRPORT BLVD STE 117 MORRISVILLE, NC USA Name of Manufacturer Contract Manufacturer SUNTECH MEDICAL DEVICES (SHENZHEN) CO.. LTD. 105 Huanguan South Road,Suite15,2-3/F Dahe Community Guanlan,Longhua New District, Shenzhen. Guangdong CHINA A Wholly Owned Subsidiary of SunTech Medical, Inc. 507 Airport Blvd Suite 11 7 Morrisville, NC USA END OF MANUFACTURER/DISTRIBUTOR LIST---

3 <hf)l\''qs / "'.,,.~/J. _,, t ::! 5 ~ "' ~.,::i:,,, DEPARTMENT OF H EALTH & HUM ANSERVICES Certificate to Foreign Government - Name of Product(s) Attachment Page 1 of 11 Name of Owner Operator SUNTECH MEDICAL, INC. 507 AIRPORT BOULEVARD SUITE 117 Morrisville, NC USA Name of Manufacturer/Distributor Legal Manufacturer/Distributor SUNTECH MEDICAL. INC. 507 AIRPORT BLVD STE 117 MORRISVILLE. NC USA Name of Product(s) System, Measurement. Blood-Pressure, Non-Invasive: Oscar 2, Model 222 & access , EVEREADY BATTERY RECHARGER , AccuWin Pro v4, English , ABPM Patient diary CABLE PC 1/F 6' , Cable. USB, Micro USB, Oscar 2, Model 250' Labeled , Power Pack Accessory Kit , USB Adapter Cable Kit , OSCAR II SYSTEM ENGLISH , Oscar 2 System , Oscar 2 System No Software , Oscar 2 Suntech Research application - Multiple unit locations: UNIT ONLY System, Measurement, Blood-Pressure, Non-Invasive: Model 222B and accessories A2, AccuWin Pro Standard Edition (SE) Bravo LA CD , CABLE ABP PC 1/F 2M B ABP System, Ela (Sorin Group) , Bravo System Bravo LA , Bravo LA w/o software APC Cuff Pack, Adult, Quick-Connect , APC Cuff Pack, Pediatric, Quick-Connect System, Measurement, Blood-Pressure, Non-Invasive: Tango+ and accessories , Finger Clip Sensor. SP02. Purelight, Adult, 1 meter System, Measurement, Blood-Pressure, Non-Invasive: 247 BP+ Vitals & accessories , Battery, Lead Acid, 6V 4.5 Ah, Sealed, Rechargeable , Power Supply. 6V@ 2.5A 120/240V. Negative to System Ground , Power Supply, 9V@ 1.7A 120/240V. Negative to System Ground , Temperature Probe, Oral. Kendall. 9 Foot Cable Temperature Probe, Rectal. Kendall, 9 Foot Cable SpO2 sensor, Adult, Reusable, Analog. Nellcor compatible , SpO2 sensor, Reusable Y Multi-Site, Analog, Dolphin , SpO2 Sensor, Adult Disposable, Analog. Dolphin SpO2 Sensor, Pediatric Disposable, Analog, Dolphin , TEMPERATURE PROBE, ORAL, FILAC 3000, 9 FOOT CABLE , TEMPERATURE PROBE, RECTAL, FILAC 3000, 9 FOOT CABLE , 247 BP Cable , SunTech 247 BP T-Tube Kit , Probe Covers, While Box, FasTemp Temperature Probe. 1 Case (5000 covers) , Probe Covers, Fas Temp Temperature Probe, 1 Box (500 covers) , Probe Covers, White Box, FasTemp Temperature Probe, 1 Box (500 covers) System, Measurement, Blood Pressure, Non-Invasive: Tango M2 and accessories , BNC to Mono Phone ECG trigger cable, RoHS , BNC to Stereo ECG trigger cable, RoHS , LPXpod SpO2 Kit with Adult Finger Sensor. Tango Tango MZ Preventative Maintenance Kit

4 4...,.,...,. '!,,,.., ('4: { ~,, DEPARTMENT OF HEALTH & HUMAN SERVICES ~ Ji'(_,-, -...,: ~..r.ra (:. Food and Drug AdmInislrabon Certificate to Foreign Government - Name of Product(s) Attachment Page 2 of 11 System, Measurement, Blood Pressure, Non-Invasive: Oscar 2, Model 250, & access A1, USB Flash Drive, AccuWin Pro v , System, Oscar 2. Model 250, Standard, Bluetooth , System, Oscar 2, Model 250, Central BP , System, Oscar 2, Model 250, Central BP, Bluetooth , System, Oscar 2, Model 250. Standard. Bluetooth Without Software , System, Oscar 2, Model 250, Central BP w/o Software , System, Oscar 2, Model 250, Central BP Blueloolh w/o Software System, Measurement, Blood Pressure, Non-Invasive: CT40, Model 260, & access , Dongle, Wi-Fi, D-Link DWA F3000 Oral/Axillary Isolation Chamber. Blue F3000 Rectal Isolation Chamber, Red , CT40 Filac 3000 Calibration Verification Plug , Masimo M-LNC 10'/3.0m Patient Cable Paper Roll, Thermal Printer, 80mm WD x 12MM LG x 33MM OD. Pack of , Cable. 6ft USB 2.0 A Male to Mini-B Spin Male 28/24AWG with Ferrite Core , SpO2 Kit, ChipOx. CT40, M , SpO2 Kit, Masimo. CT40, M , Temp Kil, Filac 3000, CT40, M , TTemp Kil, IR, CT40, M , Temp Kit, Filac 3000, CT40, M260, Rectal , Replacement IR Thermometer with cable , CT 40 IR Thermometer with cable , CT40 Rechargeable Lithium Ion Battery Replacement , System. CT40. Model 260, Standard, no power cord , System, CT40 Model 260, w/ Power Cord , System, CT40 Model 260, w/ Power Cord , System, CT40 Model 260, w/ Power Cord , System, CT40, Model 260, No Accessories System, Measurement, Blood-Pressure, Non-Invasive: Tango and accessories Headphone w/o extension cable , PWR CORD, USA, hospital Grade PWR Cord , PWR Cord , Cable, extension for headphone Name of Owner Operator SUNTECH MEDICAL, INC. 507 AIRPORT BOULEVARD SUITE 117 Morrisville, NC USA Name of Manufacturer Contract Manufacturer SUNTECH MEDICAL DEVICES (SHENZHEN) CO, LTD. 105 Huanguan South Road.Suite15.2-3/F Dahe Community Guanlan,Longhua New District, Shenzhen, Guan9dong CHINA A Wholly Owned Subsidiary of SunTech Medical, Inc. 507 Airport Blvd Suite 117 Morrisville. NC USA Name of Product(s) , 8 pin mini din Splitter Cable Pouch, Neoprene, Labeled

5 {~J-t...::~nr,-.v,,,, $ t:..... Cl DEPARTMENT OF HEALTI I & HUMAN SERVICES Certificate to Foreign Government - Name of Product(s) Attachment Page 3 of Pouch, Oscar 2, Model 250, Labeled , Strap, Shoulder, Standard, Labeled , Belt, ABP, Labeled Pouch, Cordura, Labeled , ABPM Cuff, Size 1, SunTech , ABPM Cuff, Size 2, SunTech , ABPM Cuff, Size 3, Sun Tech , ABPM Cuff, Size 4, SunTech Blood Pressure Cuff: All Purpose Cuff, One Piece Durable Cuff. All Purpose, Infant, Sun Tech Label, No Connector , Cuff, All Purpose, Child, Sun Tech Label, No Connector , Cuff, All Purpose, Small Adult. SunTech Label. No Connector , Cuff, All Purpose, Adult, SunTech Label, No Connector Cuff. All Purpose, Adult LONG, Sun Tech Label, No Connector , Cuff, All Purpose, Large Adult. Sun Tech Label. No Connector Cuff, All Purpose. Large Adult LONG, Sun Tech Label, No Connector Cuff, All Purpose. Thigh, Sun Tech Label, No Connector , Cuff, All Purpose, Infant, Sun Tech, Threaded , Cuff. All Purpose, Child, SunTech, Threaded , Cuff, All Purpose, Small Adult, Sun Tech, Threaded , Cuff, All Purpose, Adult, SunTech, Threaded , Cuff, All Purpose, Adult LONG. SunTech, Threaded , Cuff, All Purpose, Large Adult, Sun Tech, Threaded , Cuff, All Purpose. Large Adult LONG, Sun Tech, Threaded , Cuff, All Purpose, Thigh, Sun Tech, Threaded , Cuff, All Purpose, Infant, Quick Connect Male , Cuff, All Purpose, Child, Quick Connect Male Cuff. All Purpose, Small Adult. Quick Connect Male , Cuff, All Purpose, Adult, Quick Connect Male , Cuff, All Purpose, Adult LONG, Quick Connect Male Cuff. All Purpose. Large Adult, Quick Connect Male , Cuff, All Purpose, Large Adult LONG. Quick Connect Male , Cuff. All Purpose. Thigh, Quick Connect Male , Cuff, All Purpose, Infant. Rectus , Cuff, All Purpose, Child, Rectus , Cuff, All Purpose, Small Adult, Rectus , Cuff, All Purpose, Adult. Rectus , Cuff, All Purpose, Adult LONG. Rectus , Cuff, All Purpose, Large Adult, Rectus , Cuff, All Purpose, Large Adult LONG, Rectus , Cuff. All Purpose, Thigh. Rectus Cuff. All Purpose, Infant. Rectus. Bayonet, Plastic , Cuff, All Purpose, Child, Rectus, Bayonet, Plastic Cuff. All Purpose, Small Adult, Rectus. Bayonet. Plastic , Cuff. All Purpose, Adult, Rectus, Bayonet, Plastic Cuff. All Purpose, Adult LONG, Rectus, Bayonet Cuff, All Purpose, Large Adult, Rectus, Bayonet , Cuff. All Purpose. Large Adult LONG, Rectus, Bayonet Cuff, All Purpose. Thigh, Rectus Bayonet , Cuff, All Purpose. Small Adult, 2-Tube, SunTech Label, No Connector , Cuff, All Purpose, Adult, 2-Tube. SunTech Label, No Connector , Cuff, All Purpose, Adult LONG. 2-Tube. SunTech Label, No Connector , Cuff, All Purpose, Large Adult, 2-Tube, Sun Tech Label, No Connector , Cuff, All Purpose, Large Adult LONG, 2-Tube, Sun Tech Label, No Connector , Cuff, All Purpose. Small Adult, 2-Tube, SunTech, Threaded Cuff, All Purpose, Adult. 2-Tube. Sun Tech. Threaded , Cuff, All Purpose, Adult LONG. 2-Tube, Sun Tech, Threaded , Cuff, All Purpose, Large Adult, 2-Tube. SunTech, Threaded

6 :/'.dt ~...,.~ ~ \"10 :"\'.~~,. DEPART ~ f ~ ",, \. ~ l:'.t.-.,..... <4d ' MENT OF' HEAL TH & HUM AN SERVfCES Certificate to Foreign Government - Name of Product(s) Attachment Page 4 of Cuff. All Purpose. Large Adult LONG. 2-Tube, SunTech, Threaded Cuff, All Purpose, Thigh, 2-Tube, SunTech, Threaded , Cuff, All Purpose, Small Adult, 2-Tube, Quick Connect Male , Cuff, All Purpose, Adult, 2-Tube. Quick Connect Male , Cuff, All Purpose, Adult LONG. 2-Tube, Quick Connect Male , Cuff, All Purpose, Large Adult, 2-Tube, Quick Connect Male , Cuff, All Purpose, Large Adult LONG, 2-Tube. Quick Connect Male , Cuff. All Purpose, Small Adult. 2-Tube, Rectus , Cuff, All Purpose, Adult. 2-Tube, Rectus Cuff, All Purpose, Adult LONG, 2-Tube, Rectus , Cuff, All Purpose, Large Adult, 2-Tube. Rectus Cuff, All Purpose, Large Adult LONG. 2-Tube. Rectus Cuff. All Purpose, Thigh, 2-Tube, Rectus Cuff, All Purpose, Small Adult. 2-Tube, QuickConnect Male/Female , Cuff, All Purpose, Adult, 2-Tube, QuickConnect Male/Female , Cuff, All Purpose. Adult LONG, 2-Tube, QuickConnect Male/Female Cuff, All Purpose. Large Adult, 2-Tube, QuickConnect Male/Female , Cuff, All Purpose, Large Adult LONG, 2-Tube, QuickConnect Male/Female , Cuff, All Purpose, Thigh, 2-Tube, QuickConnect Male/Female Cuff, All Purpose, Small Adult, 2 -Tube, Male Bayonet, Plastic , Cuff, All Purpose, Adult, 2 - Tube, Male Bayonet, Plastic , Cuff, A ll Purpose, Adult LONG. 2-Tube, Male Bayonet, Plastic , Cuff, All Purpose, Large Adult, 2-Tube, Male Bayonet, Plastic , Cuff, All Purpose, Large Adult LONG, 2 - Tube, Male Bayonet, Plastic , Cuff, All Purpose, Thigh, 2-Tube, Male Bayonet, Plastic Cuff, SunTech Durable One-Piece Cuff, Infant, 1-Tube, Bayonet. qty , Cuff, SunTech Durable One-Piece Cuff, Child, 1-Tube, Bayonet, qty Cuff, SunTech Durable One-Piece Cuff. Small Adult, 1-Tube, Bayonet. qty Cuff. SunTech Durable One-Piece Cuff, Adult, 1-Tube, Bayonet, qty , Cuff, SunTech Durable One-Piece Cuff, Large Adult, 1-Tube. Bayonet, qty , Cuff. Sun Tech Durable One-Piece Cuff, Thigh, 1-Tube, Bayonet, qty A, Cuff, SunTech Durable One-Piece Cuff, Adult Plus, 1-Tube, Bayonet. qty C. Cuff, SunTech Dur One-Piece Cuff, Lg Adlt +. 1-Tube, Bayonet. qty , Cuff. Sun Tech Dur One-Piece Cuff, Infant. 1-T, Fem Quick Connect, Box of , Cuff, Sun Tech Dur One-Piece Cuff, Child, 1-T, Fem Quick Connect, Box of Cuff, Sun Tech Dur One-Piece Cuff, Sm Adlt, 1-T, Fem Quick Connect. Box of , Cuff, SunTech Dur One-Piece Cuff, Adult. 1-T, Fem Quick Connect, Box of , Cuff, Sun Tech Dur One-Piece Cuff, Lg Adult, 1-T, Fem Quick Connect. Box of , Cuff, SunTech Dur One-Piece Cuff, Thigh, 1-Tube, Fem Quick Connect, Box of A. Cuff, SunTech Dur One-Piece Cuff, Adult +, 1-T, Fem Quick Connect, Box of C, Cuff, SunTech Dur One-Piece Cuff, Lg Adil +. 1-T, Fem Quick Connect. Box of , Cuff, Sun Tech Dur One-Piece Cuff, Infant, 2-T, Fem Quick Connect, Box of , Cuff, Sun Tech Dur One-Piece Cuff, Child, 2-Tube, Fem Quick Connect, Box of Cuff. SunTech Dur One-Piece Cuff, Sm Adil, 2-T, Fem Quick Connect, Box of , Cuff, Sun Tech Dur One-Piece Cuff. Adult, 2-Tube, Fem Quick Connect, Box of Cuff, Sun Tech Dur One-Piece Cuff, Lg Adult, 2-T, Fem Quick Connect, Box of Cuff. SunTech Dur One-Piece Cuff, Thigh, 2-T, Fem Quick Connect. Box of A, Cuff, SunTech Dur One-Piece Cuff, Adult+, 2-T, Fem Quick Connect. Box of C, Cuff, Sun Tech Dur One-Piece Cuff, Lg Adlt +, 2-T, Fem Quick Connect. Box of , Cuff, SunTech Dur One-Piece Cuff, Infant. 1-Tube, Screw Connector. Box of Cuff. SunTech Dur One-Piece Cuff, Child. 1-Tube. Screw Connector, Box of , Cuff, Sun Tech Dur One-Piece Cuff, Sm Adult. 1-T, Screw Connector, Box of , Cuff, Sun Tech Dur One-Piece Cuff, Adult, 1-Tube, Screw Connector, Box of , Cuff, SunTech Dur One-Piece Cuff, Lg Adult, 1-Tube, Screw Connector, Box of , Cuff, Sun Tech Dur One-Piece Cuff, Thigh, 1-Tube, Screw Connector, Box of A, Cuff, SunTech Dur One-Piece Cuff, Adult +, 1-Tube, Screw Connector, Box of C, Cuff, Sun Tech Dur One-Piece Cuff, Lg Adult+, 1-T, Screw Connector, Box of , Cuff, SunTech Dur One-Piece Cuff, Infant, 2-Tube, Screw Connector, Box of 5

7 ~p, cc,.- ~""- tw., DEPARTMENT ~ \.,. ¾ "'.-.,,,... Jt tf~ ~ '17 Of. HEALTH & HUMAN SERVICES Certificate to Foreign Government - Name of Product(s) Attachment Page 5 of , Cuff. Sun Tech Dur One-Piece Cuff, Child. 2-Tube. Screw Connector, Box of , Cuff, Sun Tech Dur One-Piece Cuff, Sm Adult. 2-Tube, Screw Connector, Box of , Cuff, SunTech Dur One-Piece Cuff, Adult, 2-Tube, Screw Connector, Box of , Cuff, SunTech Dur One-Piece Cuff, Lg Adult, 2-Tube, Screw Connector, Box of , Cuff, SunTech Dur One-Piece Cuff, Thigh, 2-Tube, Screw Connector, Box of A, Cuff, Sun Tech Dur One-Piece Cuff, Adult+, 2-Tube, Screw Connector, Box of C, Cuff, SunTech Dur One-Piece Cuff, Lg Adult+, 2-T. Screw Connector, Box of , Cuff, SunTech Durable One-Piece Cuff, Infant, 1-Tube, Bayonet, Box of Cuff, Sun Tech Durable One-Piece Cuff. Child, 1-Tube, Bayonet, Box of , Cuff, SunTech Durable One-Piece Cuff, Small Adult, 1-Tube, Bayonet, Box of , Cuff, SunTech Durable One-Piece Cuff, Adult, 1-Tube, Bayonet, Box of , Cuff, SunTech Durable One-Piece Cuff. Large Adult, 1-Tube, Bayonet, Box of , Cuff, SunTech Durable One-Piece Cuff. Thigh, 1-Tube, Bayonet, Box of A, Cuff. SunTech Durable One-Piece Cuff, Adult Plus, 1-Tube, Bayonet, Box of C, Cuff. Sun Tech Dur One-Piece Cuff, Large Adult Plus, 1-Tube, Bayonet, Box of , Cuff, SunTech Durable One-Piece Cuff, Infant, 1-Tube, No Connector. Box of , Cuff. SunTech Durable One-Piece Cuff, Child, 1-Tube, No Connector, Box of , Cuff, Sun Tech Dur One-Piece Cuff, Small Adult, 1-Tube. No Connector, Box of , Cuff, Sun Tech Durable One-Piece Cuff, Adult, 1-Tube, No Connector. Box of , Cuff, SunTech Dur One-Piece Cuff, Large Adult, 1-Tube, No Connector, Box of , Cuff, SunTech Durable One-Piece Cuff, Thigh, 1-Tube, No Connector, Box of A, Cuff. SunTech Dur One-Piece Cuff, Adult Plus, 1-Tube, No Connector, Box of SC, Cuff, Sun Tech Dur One-Piece Cuff, Lg Adult+, 1-Tube. No Connector, Box of , Cuff, SunTech Durable One-Piece Cuff, Infant, 2-Tube, No Connector, Box of , Cuff, Sun Tech Durable One-Piece Cuff, Child, 2-Tube, No Connector. Box of , Cuff, SunTech Dur One-Piece Cuff, Small Adult, 2-Tube, No Connector, Box of , Cuff, SunTech Durable One-Piece Cuff, Adult, 2-Tube, No Connector. Box of Cuff. SunTech Dur One-Piece Cuff, Large Adult, 2-Tube. No Connector. Box of Cuff, SunTech Durable One-Piece Cuff. Thigh, 2-Tube, No Connector, Box of SA, Cuff, SunTech Dur One-Piece Cuff. Adult Plus, 2-Tube, No Connector, Box of C. Cuff. SunTech Dur One-Piece Cuff, Lg Adult+, 2-Tube, No Connector, Box or DO. Cuff, SunTech Dur One Piece Cuff, Infant. 1-T, Male Quick Connect, Box of , Cuff, Sun Tech Dur One Piece Cuff, Child, 1-Tube, Male Quick Connect, Box of , Cuff, SunTech Dur One Piece Cuff, Sm Adult. 1-T, Male Quick Connect, Box of DS. Cuff. SunTech Dur One Piece Cuff, Adult, 1-Tube. Male Quick Connect, Box of Dl. Cuff. SunTech Dur One Piece Cuff, Lg Adlt. 1-T, Male Quick Connect, Box of D9, Cuff, SunTech Dur One Piece Cuff, Thigh, 1-Tube, Male Quick Connect, Box of DA, Cuff, SunTech Dur One Piece Cuff. Adult+, 1-T, Male Quick Connect. Box of DC. Cuff, SunTech Dur One Piece Cuff, Lg Adult+, 1-T, M Quick Connect, Box of EO. Cuff, Sun Tech Dur One-Piece Cuff. Infant, 1-T. Male Metal Bayonet, Box of E1. Cuff, Sun Tech Dur One-Piece Cuff. Child, 1-Tube. Male Metal Bayonet. Box of E3. Cuff. Sun Tech Dur One-Piece Cuff, Sm Adult, 1-T, Male Metal Bayonet, Box of ES. Cuff. SunTech Our One-Piece Cuff. Adult, 1-Tube, Male Melal Bayonet, Box of E7. Cuff, Sun Tech Dur One-Piece Cuff. Lg Adult, 1-T, Male Metal Bayonet. Box of E9, Cuff, SunTech Dur One-Piece Cuff, Thigh, 1-T, Fem Metal Bayonet, Box of EA, Cuff, SunTech Dur One-Piece Cuff, Adult+, 1-T, Male Metal Bayonet. Box of EC, Cuff, Sun Tech Dur One-Piece Cuff. Lg Adil+, 1-T. M Metal Bayonet, Box of FO, Cuff, SunTech Dur One-Piece Cuff, Infant, 2-T, M&F Quick Connect, Box of F1, Cuff. Sun Tech Dur One-Piece Cuff, Child. 2-T, M&F Quick Connect, Box of F3, Cuff, Sun Tech Dur One-Piece Cuff, Sm Adlt, 2-T, M&F Quick Connect Box of FS, Cuff. Sun Tech Dur One-Piece Cuff. Adil, 2-T, M&F Quick Connect, Box of F7. Cuff. SunTech Dur One-Piece Cuff. Lg Adil. 2-T. M&F Quick Connect, Box of F9, Cuff, SunTech Dur One-Piece Cuff, Thigh, 2-T, M&F Quick Connect, Box of FA, Cuff, SunTech Dur One-Piece Cuff, Adil+, 2-T, M&F Quick Connect, Box of FC, Cuff, Sun Tech Dur One-Piece Cuff, Lg Ad't +, 2-T, M&F Quick Connect, Box of , Power Supply, 9V@ 5A 120I240V, Isolated Ground , Clamp, Pole, Encapsulated Screws , Tango+, Ww

8 ~>"k',:s,!~,.,.~/-,._, ~ '17 '<- l_ "' <:?r,.,,.,ao DEPARTMENT OF Ht;AL TH & HUMAN SERVICES Food and Drug AdmInistratron Silver Spring. MD Certificate to Foreign Government - Name of Product(s) Attachment Page 6 of , Tango+ ECG. 1/Vw , Tango+, Unit Only , Tango+ ECG, Unit Only Tango+ Quinton, with Headphone. without ECG, US Tango+ Kit. GE , Tango+ Kit. GE , Tango+ Kit. GE , Tango+ without ECG ~1. Tango+ with ECG , Tango+ with Test Report, no ECG , Tango+ with Test Report, with ECG , Tango+ kit, US. CS-200/AT10/ Tango+ kit, Case Tango+ kit, Case , Tango+ kit, CardioPerfect , Tango+ kit. CardioPerfect Tango+ kit. 1/Vw, CH Tango+ kit. 1/Vw, Case 12/15/Centra , Tango+ kit, 1/Vw. Max Tango+ kit, 1/Vw, QStress/O , Tango+ kit, 1/Vw, Ouest/PBI/Case , Tango+ kit, Ww, X-Scribe/StressVue , Tango+ kit, US, Philips , Tango+ Kit, Quinton US , Tango+ kit, Mortara , Tango+ with Adult Cuff. no ECG Tango+ with Adult Cuff, with ECG , Tango+ Ki t. Medset System, Measurement, Blood-Pressure. Non-Invasive: Cycle and Accessories , Clamp, Pole, Encapsulated Screws , Vitals 24-7, Temp Module , Vitals 24-7, SPO2 Module , 247 Blue Oral/Axillary Temperature Probe Well , 247 Red Rectal Temperature Probe Well , 247 Wall Mount Kit , 247 Tabletop Stand , 247 Basket , 247 Mobile Stand , 247 Red Rectal Temperature Kit , 247. SPO2 VSat Module , 247 Battery Mobile System. BP. Temperature, SpO , 247 Battery Mobile System, BP , 247 Battery Mobile System, BP, Temperature , 247 Battery Mobile System, BP, SpO Wall System, BP, Temperature. SpO , 247 Wall System, BP Wall System, BP. Temperature , 247 Wall System, BP, SpO , 247 Battery Tabletop System, BP, Temperature. SpO , 247 Battery Tabletop System. BP , 247 Battery Tabletop System, BP, Temperature , 247 Battery Tabletop System, BP. SpO , 247 Battery without Mount, BP , 247 Battery Mobile System, BP, Temperature. SpO2, Bluetooth , 247 Battery Mobile System. BP. Bluetooth , 247 Battery Mobile System, BP, Temperature, Bluetoolh , 247 Battery Mobile System, BP. SpO2, Bluetooth (l(l.()d\l~-dd. 247 Wall S'is\ern, BP, i ernperature, Sp02, B!uetooth

9 ( t _..,. ~;;t,ant't<,,,, ~ J{(_ 't, ~ 1t,tf'..noC,. A DEPARTMENTOFHEALTH&HUMAN SERVICES Silver Spnng. MD 2099:J Certificate to Foreign Government - Name of Product(s) Attachment Page 7 of , 247 Wall System, BP, Bluetooth , 247 Wall System. BP, Temperature, Bluelooth , 247 Wall System, BP, Sp02, Bluetooth Battery Tabletop System, BP, Temperature, Sp02, Bluetooth , 247 Battery Tabletop System, BP, Bluetooth , 247 Battery Tabletop System, BP, Temperature, Bluetooth , 247 Battery Tabletop System, BP, Sp02, Bluetooth , 247 Battery Mobile System, BP, Temperature, VSat Sp , 247 Battery Mobile System, BP, VSat Sp , 247 Wall System, BP, Temperature, Sp02 VSat , 247 Wall System, BP, VSat Sp , 247 Battery Tabletop System. BP, Temperature, VSat Sp , 247 Battery Tabletop System, BP, Sp02 VSat , 247 Battery Mobile System, BP, Temperature. Sp02 VSat. Bluetooth , 247 Battery Mobile System, BP. Sp02 VSat, Bluetooth , 247 Wall System. BP. Temperature. Sp02 VSat, Bluetooth , 247 Wall System, BP, Sp02 VSat, Bluetooth , 247 Battery Tabletop System, BP, Temperature, VSat Sp02. Bluetooth , 247 Battery Tabletop System, BP, Sp02 VSat, Bluetooth Blood Pressure Cuff: Disposable Cuff , Cuff, Disposable, Child, 1-Tube, Female Quick Connect. Box of , Cuff, Disposable, Small Adult, 1-Tube, Female Quick Connect. Box of , Cuff, Disposable, Adult, 1-Tube, Female Quick Connect, Box of , Cuff, Disposable, Large Adult, 1-Tube, Female Quick Connect, Box of , Cuff, Disposable. Thigh, 1-Tube, Female Quick Connect. Box of C, Cuff, Disposable, Large Adult Plus, 1-Tube, Female Quick Connect, Box of , Cuff, Disposable, Infant. 2-Tube, Female Quick Connect, Box of , Cuff, Disposable, Child, 2-Tube, Female Quick Connect, Box of , Cuff, Disposable, Small Adult. 2-Tube. Female Quick Connect, Box of , Cuff, Disposable, Adult, 2-Tube, Female Quick Connect, Box of , Cuff. Disposable. Large Adult. 2-Tube, Female Quick Connect. Box of , Cuff. Disposable, Thigh, 2-Tube, Female Quick Connect, Box of A, Cuff, Disposable, Adult Plus, 2-Tube, Female Quick Connect. Box of C, Cuff, Disposable, Large Adult Plus, 2-Tube, Female Quick Connect, Box of Cuff, Disposable, Infant, 1-Tube, Screw Connector, Box of , Cuff, Disposable, Child, 1-Tube, Screw Connector, Box of , Cuff, Disposable, Small Adult. 1-Tube, Screw Connector, Box of Cuff. Disposable, Adult. 1-Tube, Screw Connector, Box of , Cuff, Disposable, Large Adult, 1-Tube, Screw Connector, Box of , Cuff, Disposable, Thigh, 1-Tube, Screw Connector, Box of A, Cuff, Disposable. Adult Plus, 1-Tube, Screw Connector, Box of C, Cuff, Disposable, Large Adult Plus, 1-Tube, Screw Connector, Box of , Cuff, Disposable, Infant, 2-Tube, Screw Connector, Box of Cuff, Disposable. Child, 2-Tube, Screw Connector, Box of , Cuff. Disposable. Small Adult, 2-Tube, Screw Connector, Box of , Cuff, Disposable, Adult, 2-Tube, Screw Connector, Box of Cuff. Disposable, Large Adult, 2-Tube, Screw Connector, Box of , Cuff, Disposable, Thigh, 2-Tube, Screw Connector, Box of A, Cuff, Disposable, Adult Plus, 2-Tube, Screw Connector, Box of C, Cuff, Disposable, Large Adult Plus, 2-Tube, Screw Connector. Box of , Cuff. Disposable, Infant, 1-Tube, Bayonet, Box of , Cuff, Disposable, Child, 1-Tube, Bayonet, Box of Cuff, Disposable, Small Adult, 1-Tube, Bayonet, Box of , Cuff, Disposable, Adult, 1-Tube, Bayonet, Box of , Cuff, Disposable. Large Adult, 1-Tube, Bayonet, Box of , Cuff. Disposable. Thigh, 1-Tube, Bayonet, Box of A, Cuff, Disposable, Adult Plus, 1-Tube. Bayonet. Box of C, Cuff,Disposable, Large Adult Plus, 1-Tube, Bayonet Box of 20

10 . ;.t.a<~ ~-.'-<,- ( ~ DEPARTMENT OF HSAL TH & HUMAN SERVICES,::-i~l.. Food and Drug Adrninislration Certificate to Foreign Government - Name of Product(s) Attachment Page 8 of Cuff. Disposable. Infant. 2-Tube, Bayonet. Box of , Cuff, Disposable, Child. 2-Tube, Bayonet. Box of , Cuff, Disposable, Small Adult. 2-Tube. Bayonet, Box of , Cuff. Disposable. Adult. 2-Tube. Bayonet, Box of , Cuff, Disposable, Large Adult, 2-T ube, Bayonet, Box of , Cuff, Disposable, Thigh, 2-Tube, Bayonet, Box of SA, Cuff, Disposable. Adult Plus. 2-Tube. Bayonet. Box of C, Cuff, Disposable, Large Adult Plus, 2-Tube, Bayonet, Box of Cuff. Disposable, Infant, 1-Tube. No Connector, Box of , Cuff, Disposable. Child, 1-Tube, No Connector, Box of , Cuff. Disposable. Small Adult, 1-Tube, No Connector, Box of , Cuff. Disposable. Adult, 1-Tube, No Connector. Box of , Cuff, Disposable, Large Adult, 1-Tube. No Connector. Box of , Cuff, Disposable, Thigh, 1-Tube, No Connector, Box of GA, Cuff, Disposable, Adult Plus, 1-Tube, No Connector. Box of C. Cuff. Disposable. Large Adult Plus. 1-Tube,No Connector., Box of , Cuff, Disposable, Infant. 2-Tube, No Connector, Box of Cuff. Disposable, Child. 2-Tube. No Connector, Box of , Cuff, Disposable, Small Adult, 2-Tube, No Connector, Box of , Cuff, Disposable, Adult. 2-Tube, No Connector, Box of , Cuff, Disposable, Large Adult. 2-Tube. No Connector, Box of , Cuff, Disposable, Thigh, 2-Tube, No Connector, Box of A, Cuff, Disposable, Adult Plus, 2-Tube, No Connector, Box of C, Cuff, Disposable, Large Adult Plus. 2-Tube. No Connector, Box of , Cuff, Disposable. Neonate #1, 1-Tube. Male Slip Luer, Box of Cuff. Disposable, Neonate #2, 1-Tube, Male Slip Luer, Box of , Cuff, Disposable. Neonate #3, 1-Tube, Male Slip Luer, Box of Cuff, Disposable. Neonate #4, 1-Tube, Male Slip Luer, Box of Cuff, Disposable, Neonate #5, 1-Tube, Male Slip Luer, Box of , Cuff, Disposable, Neonate #1, 2-Tube. Male Slip Luer. Box of Cuff. Disposable, Neonate #2. 2-Tube. Male Slip Luer, Box of , Cuff. Disposable, Neonate #3, 2-Tube, Male Slip Luer. Box of , Cuff, Disposable, Neonate #4, 2-Tube, Male Slip Luer. Box of , Cuff, Disposable, Neonate #5, 2-Tube, Male Slip Luer, Box of , Cuff, Disposable, Neonate #5. 1-Tube, Male Bayonet. Box of , Cuff, Disposable. Neonate #5. 2-Tube, Male Bayonet, Box of , Cuff, Disposable, Neonate #4. 2-Tube, Male Bayonet, Box of , Cuff, Disposable, Neonate #3, 2-Tube, Male Bayonet, Box of , Cuff, Disposable, Neonate #2, 2-Tube, Male Bayonet, Box of Cuff. Disposable, Neonate #1, 2-Tube, Male Bayonet, Box of Cuff, Disposable, Neonate #2, 1-Tube. Male Bayonet, Box of , Cuff, Disposable, Neonate #3, 1-Tube, Male Bayonet, Box of , Cuff. Disposable. Neonate #4. 1-Tube, Male Bayonet, Box of Cuff. Disposable. Neonate #1, 1-Tube, Male Bayonet, Box of AO, Cuff, Disposable, Infant. 2-Tube, Quick Connect Male and Female. Box of A 1, Cuff, Disposable, Child. 2-Tube, Quick Connect Male and Female, Box of A3, Cuff, Disposable, Sm Adi!, 2-Tube, Quick Connect Male and Female, Box of A5, Cuff, Disposable, Adult, 2-Tube, Quick Connect Male and Female, Bo>< of A7. Cuff, Disposable. Lg Adil. 2-Tube, Quick Connect Male and Fernale, Box of A9, Cuff, Disposable, Thigh, 2-Tube, Quick Connect Male and Female. Box of AA, Cuff, Disposable, Adil+, 2-Tube, Quick Connect Male and Female, Box of AC. Cuff. Disposable, Lg Adil +, 2-Tube. Quick Connect Male and Female. Box of , Cuff. Disposable, Infant, 1-T ube. Male Quick Connect, Box of , Cuff, Disposable, Child, 1-Tube, Male Quick Connect. Box of D3, Cuff, Disposable, Small Adult, 1-Tube, Male Quick Connect, Box cf D5, Cuff, Disposable, Adult, 1-Tube. Male Quick Connect, Box of , Cuff, Disposable, Large Adult, 1-Tube, Male Quick Connect, Box of , Curr, Oi<5posable, Thigh, 1 -Tuba, Male Ouick Connect, Box of 20

11 ..:,:,~.a.h(.:($,{;)' ",,.., { ~, DEPARTMENT OF HEALTH & HU:vlAN SERVICES t "'' -::::i,e "'«,n.,i'o Public Health Sorvice Food and Drug Admirnslrat1on Certificate to Foreign Government - Name of Product(s) Attachment Page 9 of DA. Cuff. Disposable. Adult Plus. 1-Tube, Male Quick Connect. Box of DC. Cuff. Disposable. Large Adult Plus. 1-Tube. Male Quick Connect, Box of Fl. Cuff. Disposable. #6. 1-Tube, Slip Luer. Box of F3, Cuff, Disposable. #7. 1-Tube. Slip Luer, Box of Single Patient Use Kit - Sm Adlt Disp Cuff with Fem Quick Conn and Mic Pads Single Patient Use Kit - Adil Oisp Cuff with Fem Quick Conn and Mic Pads Single Patient Use Kit - Adlt Lng Disp Cuff w/ Fem Quick Conn and Mic Pads , Single Patient Use Kit - Lrg Adil Disp Cuff w/ Fem Quick Conn and Mic Pads Single Patient Use Kit - Lrg Adil Lng Disp Cuff w/ F Quick Conn and Mic Pads Cuff. Vinyl. Infant. 1-Tube. Bayonet, Box of Cuff, Vinyl, Child. 1-Tube. Bayonet, Box of Cuff. Vinyl. Small Adult. 1-Tube. Bayonet, Box of , Cuff. Vinyl, Adult. 1-Tube, Bayonet. Box of , Cuff. Vinyl, Large Adult, 1-Tube, Bayonet. Box of , Cuff, Vinyl, Thigh, 1-Tube. Bayonet. Box of A. Cuff. Vinyl, Adult Plus. 1-Tube, Bayonet. Box of C. Cuff. Vinyl, Large Adult Plus. 1-Tube, Bayonet. Box of , Cuff, Vinyl, Infant, 1-Tube, Female Quick Connect, Box of Cuff. Vinyl. Child. 1-Tube. Female Quick Connect. Box of , Cuff, Vinyl, Small Adult. 1-Tube, Female Quick Connect. Box of Cuff, Vinyl, Adult, 1-Tube, Female Quick Connect, Box of , Cuff. Vinyl, Large Adult. 1-Tube, Female Quick Connect. Box of Cuff. Vinyl. Thigh, 1-Tube, Female Quick Connect. Box of A. Cuff. Vinyl, Adult Plus. 1-Tube, Female Quick Connect. Box of C, Cuff, Vinyl, Large Adult Plus. 1-Tube. Female Quick Connect. Box of Cuff. Vinyl, Infant. 2-Tube. Female Quick Connect. Box of Cuff. Vinyl. Child. 2-Tube, Female Quick Connect. Box of Cuff. Vinyl. Small Adult. 2-Tube. Female Quick Connect. Box of Cuff, Vinyl, Adult. 2-Tube. Female Quick Connect, Box of Cuff. Vinyl, Large Adult. 2-Tube. Female Quick Connect. Box of Cuff. Vinyl, Thigh. 2-Tube, Female Quick Connect. Box of A, Cuff, Vinyl, Adult Plus, 2-Tube. Female Quick Connect. Box of C. Cuff. Vinyl. Large Adult Plus. 2-Tube. Female Quick Connect. Box of , Cuff. Vinyl, Infant. 1-Tube, Screw Connector. Box of , Cuff, Vinyl, Child, 1-Tube, Screw Connector. Box of Cuff, Vinyl, Small Adult. 1-Tube. Screw Connector. Box of , Cuff, Vinyl. Adult. 1-Tube. Screw Connector. Box of Cuff, Vinyl, Large Adult, 1-Tube, Screw Connector, Box of , Cuff, Vinyl. Thigh. 1-Tube. Screw Connector. Box of A. Cuff. Vinyl. Adult Plus. 1-Tube. Screw Connector, Box of C. Cuff, Vinyl. Large Adult Plus. 1-Tube. Screw Connector. Box of , Cuff, Vinyl, Infant, 2-Tube, Screw Connector. Box of , Cuff. Vinyl. Child. 2-Tube. Screw Connector. Box of , Cuff. Vinyl, Small Adult. 2-Tube. Screw Connector. Box of Cuff. Vinyl, Adult, 2-Tube, Screw Connector, Box or Cuff, Vinyl, Large Adult, 2-Tube, Screw Connector, Box of Cuff. Vinyl. Thigh. 2-Tube. Screw Connector. Box of A. Cuff. Vinyl, Adult Plus. 2-Tube. Screw Connector. Box of C. Cuff. Vinyl, Large Adult Plus. 2-Tube. Screw Connector. Box of , Cuff. Vinyl, Infant, 1-Tube. No Connector. Box of , Cuff, Vinyl, Child. 1-Tube, No Connector. Box or Cuff, Vinyl. Small Adult, 1-Tube, No Connector. Box of , Cuff, Vinyl, Adult, 1-Tube, No Connector, Box of , Cuff, Vinyl. Large Adult, 1-Tube, No Connector, Box or Cuff, Vinyl. Thigh, 1-Tube. ~ 1 0 Connector, Box of A. Cuff. Vinyl, Adult Plus. 1-Tube, No Connector. Box of C, Cuff, Vinyl, Large Adult Plus. 1-Tube, No Connector. Box of , Cuff, V inyl, l n f'ont, :l T ubo. PJ o C o nn.odo r. Qox of 2 f'l

12 Food and Drug Adnunistration Certificate to Foreign Government - Name of Product(s) Attachment Page 10 of Cuff, Vinyl, Child. 2-Tube, No Connector. Box of , Cuff, Vinyl, Small Adult. 2-Tube, No Connector, Box of , Cuff. Vinyl, Adult, 2-Tube, No Connector, Box of , Cuff, Vinyl, Large Adult, 2-Tube, No Connector, Box of , Cuff, Vinyl, Thigh, 2-Tube, No Connector, Box of A, Cuff, Vinyl, Adult Plus, 2-Tube, No Connector, Box of BOO-SC, Cuff. Vinyl, Large Adult Plus. 2-Tube. No Connector. Box of , Cuff, Vinyl. Infant, 1-Tube, Male Quick Connector. Box of Cuff. Vinyl. Child, 1-Tube, Male Quick Connector, Box of , Cuff, Vinyl, Small Adult, 1-Tube. Male Quick Connector, Box of , Cuff. Vinyl, Adult, 1-Tube, Male Quick Connector, Box of Cuff. Vinyl. Large Adult. 1-Tube, Male Quick Connector, Box of Cuff, Vinyl, Thigh, 1-Tube, Male Quick Connector. Box of A, Cuff, Vinyl, Adult Plus. 1-Tube, Male Quick Connector, Box of 20 gs c. Cuff, Vinyl, Large Adult Plus, 1-Tube. Male Quick Connector, Box of , Cuff, Vinyl, Infant, 2-Tube, M & F Quick Connector. Box of Cuff, Vinyl, Child, 2-Tube, M & F Quick Connector, Box of Cuff, Vinyl. Small Adult. 2-Tube, M & F Quick Connector, Box of , Cuff, Vinyl, Adult, 2-Tube, M & F Quick Connector, Box of , Cuff, Vinyl, Large Adult, 2-Tube, M & F Quick Connector, Box of , Cuff, Vinyl, Thigh, 2-Tube, M & F Quick Connector, Box of A, Cuff, Vinyl, Adult Plus, 2-Tube. M & F Quick Connector, Box of SC, Cuff, Vinyl, Large Adult Plus, 2-Tube. M & F Quick Connector, Box of , Cuff, Vinyl, Infant, Private Label. Prolife , Cuff.Vinyl, Child, Private Label, Prolife , Cuff, Vinyl, Child Long, Private Label, ProLife Cuff. Vinyl. Small Adult. Private Label, Prolife , Cuff.V inyl, Small Adult Long, Private Label. ProLife , Cuff, Vinyl, Adult, Private Label, Prolife , Cuff.Vinyl, Adult Long, Private Label. Prolife Cuff, Vinyl, Large Adult, Private Label, Prolife Cuff, Vinyl, Large Adult Long, Private Label, Prolife A-01, Cuff, Vinyl, Adult Plus, Private Label, Prolife 98-0BOC-01. Cuff, Vinyl, Large Adult Plus, Private Label, Prolife , Cuff, Vinyl, Thigh, Private Label, Prolife Tango M2 microphone. 18" Tango M2 Microphone, 12" , Tango M2 USB Cable Kit , Tango M2 without ECG, no cables , Tango M2 with ECG , Tango M2, Test Report, No ECG, No Power Cord , Tango M2 Kit. US. Case/ , Tango M2 Kit. US, CH , Tango M2 Kit, US, QStress/Q Tango M2 Ki t. US, Xscribe/StressVue Tango M2 Kit. US. CardioPerfect Tango M2, US, ST80i , Sun Tech Oscar 2 Carrying Case Wall Bracket Kit, CT , CABLE, TANGO PAT., 15' Patient leads, ECG cable , Cable. RS232, Schiller. RoHS , Orbit K Cuff, Small Adult , Orbit K Cuff, Adult , Orbit K Cuff, LarGe Adult , Orbit K Cuff-Adult Plus , Orbit K Cuff, w/mic2, Small Adult , Orbit K Cuff. w/mic2 - Adult

13 ( 1-!1.1".._',!lf,U'lt'~ 'ft DEPARTMENT 'tqs~l.. OF HEAL TH & HUMAN SERVICES Sliver Spring, MD Certificate to Foreign Government - Name of Product(s) Attachment Page 11 of , Orbit K Cuff w/mic2. - Large Adult , Orbit K Cuff w/mic2,- Adult Plus , Tango+, US , Tango+ ECG, US , Tango+ kit, US, case/ , Tango+ kit, US, CH , TMgo+ kit, US, CasG 12/15/ Centra , Tango+ kit, US, Max Tango+ kit, US. QStress/O , Tango+ kit, US. QuesVPBI/ , Tango+ kit, US, CardioPerfect Tango+ kit, US, X-Scribe/ END OF PRODUCT LIST