1,155 results · 9ms · 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.

Oncotype DX Breast Recurrence Score® Test

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Genomic Health Inc.·3 devices

AmoyDx® ROS1 Gene Fusions Detection Kit

Basic UDI-DI
EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·1 device

AmoyDx® ROS1 Gene Fusions Detection Kit

Basic UDI-DI
EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·1 device

AmoyDx® EML4-ALK Fusion Gene Detection Kit

Basic UDI-DI
EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·1 device

Super-ARMS® EGFR Mutation Detection Kit

Basic UDI-DI
EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·1 device

AmoyDx® HANDLE HRR NGS Panel

Basic UDI-DI
EU IVDD · Eu Ivd General ·Amoy Diagnostics Co., LTD.·1 device

ONE STEP Anti-HIV (1&2) Test

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·InTec PRODUCTS, INC.·1 device

ONE STEP Anti-HIV (1&2) Test

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·InTec PRODUCTS, INC.·1 device

Rapid Anti-HCV Test

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·InTec PRODUCTS, INC.·1 device

Rapid Anti-HCV Test

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·InTec PRODUCTS, INC.·1 device

Rapid Anti-HCV Test

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·InTec PRODUCTS, INC.·1 device

ONE STEP Anti-HIV (1&2) Test

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·InTec PRODUCTS, INC.·1 device

ONE STEP Anti-HIV (1&2) Test

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·InTec PRODUCTS, INC.·1 device

Rapid Anti-HCV Test

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·InTec PRODUCTS, INC.·1 device

AutoLumo Analyzer

Basic UDI-DI
EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·2 devices

AutoLumo Analyzer

Basic UDI-DI
EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·2 devices

AutoLumo Analyzer

Basic UDI-DI
EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·2 devices

AutuLumo Analyzer

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·2 devices

Total Thyroxine Quantitative Detection KIT (Chemiluminescent Immunoassay)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·1 device

Cyfra21-1 Quantitative Detection KIT (Chemiluminescent Immunoassay)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·1 device