114 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.

Kit Água

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Plasticerveira - Transformação de Plástico, Lda·1 device

Dengue NS1 Ag FIA Kit

Basic UDI-DI
EU IVDD · Eu Ivd General ·Shenzhen Zijian Biotechnology Co., Ltd·1 device

H. Pylori Ag FIA Kit

Basic UDI-DI
EU IVDD · Eu Ivd General ·Shenzhen Zijian Biotechnology Co., Ltd·1 device

VIRAPID® LEGIONELLA PNEUMOPHILA Ag FIA

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Vircell, S.L·1 device

SARS-CoV-2 Ag FIA Test VID44 

Basic UDI-DI
EU IVDD · Eu Ivd General ·VivaChek Biotech (Hangzhou) Co., Ltd.·1 device

Progesterone (CLIA)

Basic UDI-DI
EU IVDR · Eu Ivd Class B ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·2 devices

C2KH002

Basic UDI-DI
EU IVDD · Eu Ivd General ·Hangzhou Cybereagen Biotech Co., Ltd.·1 device

β-Hydroxybutyric Acid Test Kit (Enzymatic Method)

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

Sentosa SA EBV Quantitation Controls (4x2)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Vela Operations Singapore Pte. Ltd.·1 device

Heparin Binding Protein Chemiluminescence Immunoassay Kit

Basic UDI-DI
EU IVDD · Eu Ivd General ·Nanjing RealMind Biotech Co., Ltd.·1 device

RF-IgM Chemiluminescent Immunoassay Kit

Basic UDI-DI
EU IVDD · Eu Ivd General ·Maccura Biotechnology Co., Ltd. ·1 device

Multichem IA Level 3

Basic UDI-DI
EU IVDD · Eu Ivd General ·Techno-path Manufacturing Ltd.·1 device

SARS-CoV-2/Flu A/FIu B Ag FIA Test VID47 

Basic UDI-DI
EU IVDD · Eu Ivd General ·VivaChek Biotech (Hangzhou) Co., Ltd.·1 device

Human Micro-albuminuria (mALB) Detection Kit(Nephelometry)

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

Human Micro-albuminuria (mALB) Detection Kit (Nephelometry)

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

Ferritin (FER) Test Kit (Immunofluorescence)

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

Anti-Mullerian Hormone (AMH) Test Kit (Immunofluorescence)

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

Ferritin (FER) Test Kit (Immunofluorescence)

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

Anti-Mullerian Hormone (AMH) Test Kit (Immunofluorescence)

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

Testosterone (Testo) Test Kit (Immunofluorescence)

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