82 results
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12ms
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Sources: EU EUDAMED, US FDA
Abon Biopharm(Hangzhou) Co., Ltd
Manufacturer
🇨🇳 China·123 Basic UDI-DIs·123 Devices·1 Importer·TÜV SÜD Product Service GmbH, INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, GMED SAS, and GMED SAS
CeCert/115/W/E.1
Certificate
IVDD Annex IV Section 4·Sansure Biotech Inc.·CeCert Sp. z o.o.·1 Basic UDI-DI
HCV ANTIBODY -RT & POC
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Abon Biopharm(Hangzhou) Co., Ltd·On the market
HBSAG - RT & POC
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Abon Biopharm(Hangzhou) Co., Ltd·On the market
HCV Hepatitis C Virus Rapid Test Device (Serum/Plasma)
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Abon Biopharm(Hangzhou) Co., Ltd·1 device
HBsAg Hepatitis B Surface Antigen Rapid Test Device (Whole Blood/Serum/Plasma)
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Abon Biopharm(Hangzhou) Co., Ltd·1 device
TÜV Rheinland LGA Products GmbH
Notified body
🇩🇪 Germany·689 Manufacturers·17345 Basic UDI-DIs
No. 11 0498 CN/NB
Certificate
IVDD Annex IV Section 4·Abon Biopharm(Hangzhou) Co., Ltd·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390·2 Basic UDI-DIs
INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390
Notified body
🇨🇿 Czechia·16 Manufacturers·135 Basic UDI-DIs
POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.
Notified body
🇵🇱 Poland·272 Manufacturers·5185 Basic UDI-DIs
INSTI HIV-1/HIV-2 ANTIBODY TEST KIT
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·1 device
INSTI HIV ANTIBODY SELF-TEST
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·1 device
INSTI HCV CONTROL TEST KIT
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·1 device
INSTI HIV ANTIBODY SELF-TEST
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·1 device
INSTI HCV ANTIBODY TEST KIT
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·1 device
INSTI HCV ANTIBODY TEST KIT
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·1 device
INSTI HCV ANTIBODY TEST KIT
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·1 device
INSTI HCV ANTIBODY TEST KIT
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·1 device
INSTI HCV ANTIBODY TEST KIT
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·1 device
INSTI HIV ANTIBODY SELF-TEST
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·1 device