EC Certificate Full Quality Assurance System
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1 CE-ITA-NA-PS Rev. 0.0 PRJC MSL-ITA 14 December 2019 This is to certify that the quality system of: ANGELANTONI LIFE SCIENCE SRL For design, production and final product inspection/testing of: Human Tissues Cooling Units Has been assessed with respect to: The conformity assessment procedure described in Article 11.3.a and Annex II excluding section 4 (Module H2) of Council Directive 93/42/EEC on Medical Devices, as amended and found to comply. Further details of the product(s) and conditions for certification are given overleaf. Place and Date: Høvik, 30 October 2017 For: DNV GL NEMKO PRESAFE AS PROD 021 Notified Body No.: 2460 Alessandra Rinna The Certificate has been digitally signed. See for more info Notice: The Certificate is subject to terms and conditions as set out in the Certification Agreement. Failure to comply may render this Certificate invalid. MSD-CO-078 DNV GL NEMKO PRESAFE AS - Veritasveien 3, N-1363 Høvik, Norway - Registered Enterprise No: NO MVA Page 1 of 3
2 CE-ITA-NA-PS Rev. 0.0 PRJC MSL-ITA 14 December 2019 Jurisdiction Application of Council Directive 93/42/EEC of 14 June 1993, adopted as Forskrift om Medisinsk Utstyr by the Norwegian Ministry of Health and Care Services. Certificate history: Revision Description Issue Date 0.0 Original Certificate - Replaces Certificate CE-ITA-DNV Rev. 5.0 (NB 0434), following transfer of Notified Body functions to DNV GL NEMKO Presafe AS (NB 2460) Products covered by this Certificate: Product Description Product Name Class Blood and Blood Cells Cooling Units Blood Banks IIa Human Tissues (Blood, blood cells, tissues and fluids) Cooling Units Human Tissues (Blood, blood cells, tissues and fluids) Cooling Chambers Human Tissues (Blood, blood cells, tissues and fluids) Freezer Chambers Freezers Refrigeration Chambers Freezer Chambers IIa IIa IIa The complete list of devices is filed with the Notified Body Sites covered by this certificate Site Name ANGELANTONI LIFE SCIENCE S.r.l. Address MSD-CO-078 DNV GL NEMKO PRESAFE AS - Veritasveien 3, N-1363 Høvik, Norway - Registered Enterprise No: NO MVA Page 2 of 3
3 CE-ITA-NA-PS Rev. 0.0 PRJC MSL-ITA 14 December 2019 Terms and conditions The certificate is subject to the following terms and conditions: Any producer (see 2001/95/EC for a precise definition) is liable for damage caused by a defect in his product(s), in accordance with directive 85/374/EEC, as amended, concerning liability of defective products. The certificate is only valid for the products and/or manufacturing premises listed above. The Manufacturer shall fulfil the obligations arising out of the quality system as approved and uphold it so that it remains adequate and efficient. The Manufacturer shall inform Presafe of any intended updating of the quality system and Presafe will assess the changes and decide if the certificate remains valid. Periodical audits will be held, in order to verify that the Manufacturer maintains and applies the quality system. Presafe reserves the right, on a spot basis or based on suspicion, to pay unannounced visits. The following may render this Certificate invalid: Changes in the quality system affecting production. Periodical audits not held within the allowed time window. Conformity declaration and marking of product When meeting with the terms and conditions above, the producer may draw up an EC declaration of conformity and legally affix the CE mark followed by the Notified Body identification number of Presafe. End of Certificate MSD-CO-078 DNV GL NEMKO PRESAFE AS - Veritasveien 3, N-1363 Høvik, Norway - Registered Enterprise No: NO MVA Page 3 of 3
4 CE-ITA-NA-PS Rev. 0.0 PRJC MSL-ITA 29 October 2019 This is to certify that the quality system of: ANGELANTONI LIFE SCIENCE SRL For design, production and final product inspection/testing of: Large Sterilisers and Washer Disinfectors Has been assessed with respect to: The conformity assessment procedure described in Article 11.3.a and Annex II excluding section 4 (Module H2) of Council Directive 93/42/EEC on Medical Devices, as amended and found to comply. Further details of the product(s) and conditions for certification are given overleaf. Place and Date: Høvik, 30 October 2017 For: DNV GL NEMKO PRESAFE AS PROD 021 Notified Body No.: 2460 Alessandra Rinna The Certificate has been digitally signed. See for more info Notice: The Certificate is subject to terms and conditions as set out in the Certification Agreement. Failure to comply may render this Certificate invalid. MSD-CO-078 DNV GL NEMKO PRESAFE AS - Veritasveien 3, N-1363 Høvik, Norway - Registered Enterprise No: NO MVA Page 1 of 3
5 CE-ITA-NA-PS Rev. 0.0 PRJC MSL-ITA 29 October 2019 Jurisdiction Application of Council Directive 93/42/EEC of 14 June 1993, adopted as Forskrift om Medisinsk Utstyr by the Norwegian Ministry of Health and Care Services. Certificate history: Revision Description Issue Date 0.0 Original Certificate - Replaces Certificate CE-ITA-NA 2.0 (NB 0434), following transfer of Notified Body functions to DNV GL NEMKO Presafe AS (NB 2460) Products covered by this Certificate: Product Description Product Name Class Large Steam steriliser Eurosteam MDSTM IIb Washer Disinfector MDWSD series IIb The complete list of devices is filed with the Notified Body Sites covered by this certificate Site Name ANGELANTONI LIFE SCIENCE S.r.l. Address MSD-CO-078 DNV GL NEMKO PRESAFE AS - Veritasveien 3, N-1363 Høvik, Norway - Registered Enterprise No: NO MVA Page 2 of 3
6 CE-ITA-NA-PS Rev. 0.0 PRJC MSL-ITA 29 October 2019 Terms and conditions The certificate is subject to the following terms and conditions: Any producer (see 2001/95/EC for a precise definition) is liable for damage caused by a defect in his product(s), in accordance with directive 85/374/EEC, as amended, concerning liability of defective products. The certificate is only valid for the products and/or manufacturing premises listed above. The Manufacturer shall fulfil the obligations arising out of the quality system as approved and uphold it so that it remains adequate and efficient. The Manufacturer shall inform Presafe of any intended updating of the quality system and Presafe will assess the changes and decide if the certificate remains valid. Periodical audits will be held, in order to verify that the Manufacturer maintains and applies the quality system. Presafe reserves the right, on a spot basis or based on suspicion, to pay unannounced visits. The following may render this Certificate invalid: Changes in the quality system affecting production. Periodical audits not held within the allowed time window. Conformity declaration and marking of product When meeting with the terms and conditions above, the producer may draw up an EC declaration of conformity and legally affix the CE mark followed by the Notified Body identification number of Presafe. End of Certificate MSD-CO-078 DNV GL NEMKO PRESAFE AS - Veritasveien 3, N-1363 Høvik, Norway - Registered Enterprise No: NO MVA Page 3 of 3
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