32 results · 8ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

APO A1 and B Calibrator

Basic UDI-DI
EU IVDR · Eu Ivd Class B ·Beckman Coulter Inc.·1 device

Genvinset® PAI-1/FXIII multiplex

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Blackhills Diagnostic Resources S.L.U.·3 devices

Apolipoprotein E (ApoE)Assay Kit (Immunoturbidimetric Method)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Shenzhen AmTech Bioengineering Ltd., Inc.·1 device

Apolipoprotein B (Apo B) Kit(Immunoturbidimetric Method)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Zybio Inc.·1 device

Apolipoprotein A1 (Apo A1) Kit (Immunoturbidimetric Method)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Zybio Inc.·1 device

fPSA Rapid Test

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·1 device

PSA Rapid Test

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·1 device

PSA Rapid Test

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·1 device

fPSA Rapid Test

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·1 device

Human ApoE Genetic Polymorphism Detection Kit (PCR-Fluorescence Probing)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·1 device

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