1,112 results · 17ms · 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.

DAU Secondary cut-off Multi-Drug Calibrator

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

GastroPanel Four-in-Oneᵀᴹ

Basic UDI-DI
EU IVDD · Eu Ivd General ·Biohit Oyj·1 device

BIOHIT Total 25OH Vitamin D

Basic UDI-DI
EU IVDD · Eu Ivd General ·Biohit Oyj·1 device

GastroPanel® 𝘏𝘦𝘭𝘪𝘤𝘰𝘣𝘢𝘤𝘵𝘦𝘳 𝘱𝘺𝘭𝘰𝘳𝘪

Basic UDI-DI
EU IVDD · Eu Ivd General ·Biohit Oyj·1 device

GastroPanel® Pepsinogen II

Basic UDI-DI
EU IVDD · Eu Ivd General ·Biohit Oyj·1 device

GastroPanel® Pepsinogen I

Basic UDI-DI
EU IVDD · Eu Ivd General ·Biohit Oyj·1 device

GastroPanel® Unified

Basic UDI-DI
EU IVDD · Eu Ivd General ·Biohit Oyj·1 device

𝘏𝘦𝘭𝘪𝘤𝘰𝘣𝘢𝘤𝘵𝘦𝘳 𝘱𝘺𝘭𝘰𝘳𝘪 IgG

Basic UDI-DI
EU IVDD · Eu Ivd General ·Biohit Oyj·1 device

Pepsinogen II

Basic UDI-DI
EU IVDD · Eu Ivd General ·Biohit Oyj·1 device

Pepsinogen I

Basic UDI-DI
EU IVDD · Eu Ivd General ·Biohit Oyj·1 device

BIOHIT Calprotectin

Basic UDI-DI
EU IVDD · Eu Ivd General ·Biohit Oyj·1 device

BIOHIT ColonView QT Control

Basic UDI-DI
EU IVDD · Eu Ivd General ·Biohit Oyj·1 device

nAbCyte Anti-AAVRh74var HB-FE Assay

Basic UDI-DI
EU IVDD · Eu Ivd General ·Laboratory Corporation of America Holdings·1 device

Anti-AAV9 nAb Assay

Basic UDI-DI
EU IVDD · Eu Ivd General ·Laboratory Corporation of America Holdings·1 device

Anti-AAV6 nAb Assay

Basic UDI-DI
EU IVDD · Eu Ivd General ·Laboratory Corporation of America Holdings·1 device

ApoE Genotype Test

Basic UDI-DI
EU IVDD · Eu Ivd General ·Laboratory Corporation of America Holdings·1 device

DELFIA Xpress PAPP-A

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Wallac Oy·1 device

NEOMASS AAAC PLUS

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Labsystems Diagnostics Oy·1 device

Chlamydia Pneumoniae IgA EIA

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Labsystems Diagnostics Oy·1 device

Neonatal Phenylalanine Controls

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Labsystems Diagnostics Oy·1 device