92 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.

NovelCoronavirus (COVID-19)AntigenTest Kit(ColloidalGold)for self-testing

Basic UDI-DI
EU IVDD · Eu Ivd Self Testing ·Hangzhou Laihe Biotech Co., Ltd.·1 device

COVID-19 and Influenza A/B Antigen Test Kit for self-testing

Basic UDI-DI
EU IVDD · Eu Ivd Self Testing ·Hangzhou Laihe Biotech Co., Ltd.·1 device

BioGerm SARS-CoV-2 Antigen Self Test

Basic UDI-DI
EU IVDD · Eu Ivd Self Testing ·Shanghai BioGerm Medical Technology Co., Ltd.·1 device

BioGerm SARS-CoV-2 Antigen Self Test

Basic UDI-DI
EU IVDD · Eu Ivd Self Testing ·Shanghai BioGerm Medical Technology Co., Ltd.·1 device

BioGerm SARS-CoV-2 Antigen Self Test

Basic UDI-DI
EU IVDD · Eu Ivd Self Testing ·Shanghai BioGerm Medical Technology Co., Ltd.·1 device

SARS-CoV-2 Antigen Test Cassette

Basic UDI-DI
EU IVDD · Eu Ivd Self Testing ·Jiangsu Mole Bioscience Co., LTD.·1 device

SARS-CoV-2 Antigen Test Cassette

Basic UDI-DI
EU IVDD · Eu Ivd Self Testing ·Jiangsu Mole Bioscience Co., LTD.·1 device

Human Papillomavirus Self Sample Collection Kit

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Jiangsu Mole Bioscience Co., LTD.·4 devices

Fortel Ultra Sensitive Pregnancy Midstream 2-Test

Basic UDI-DI
EU IVDD · Eu Ivd Self Testing ·BIOEUROPE GmbH·1 device

Fortel Ulcer (H. pylori) Screening Test

Basic UDI-DI
EU IVDD · Eu Ivd Self Testing ·Biomerica, Inc.·1 device

Fortel Kidney Disease (Microalbumin) Screening Test

Basic UDI-DI
EU IVDD · Eu Ivd Self Testing ·Biomerica, Inc.·1 device

Fortel Ovulation Prediction Test

Basic UDI-DI
EU IVDD · Eu Ivd Self Testing ·Biomerica, Inc.·1 device

Fortel Prostate (PSA) Screening Test

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List B ·Biomerica, Inc.·1 device

EZ Detect™ Fecal Occult Blood Test Professional

Basic UDI-DI
EU IVDD · Eu Ivd Self Testing ·Biomerica, Inc.·1 device

EZ Detect Home Test for Hidden Blood in The Stool

Basic UDI-DI
EU IVDD · Eu Ivd Self Testing ·Biomerica, Inc.·1 device

EZ Detect Colon Disease Test

Basic UDI-DI
EU IVDD · Eu Ivd Self Testing ·Biomerica, Inc.·1 device

Fortel Ultra Sensitive Pregnancy Midstream 2-Test

Basic UDI-DI
EU IVDD · Eu Ivd Self Testing ·Biomerica, Inc.·1 device

Fortel Ultra Sensitive Pregnancy Midstream 1-Test

Basic UDI-DI
EU IVDD · Eu Ivd Self Testing ·Biomerica, Inc.·1 device

Fortel Ultra Sensitive Pregnancy Midstream 1-Test

Basic UDI-DI
EU IVDD · Eu Ivd Self Testing ·BIOEUROPE GmbH·1 device

Fortel Kidney Disease (Microalbumin) Screening Test

Basic UDI-DI
EU IVDD · Eu Ivd Self Testing ·BIOEUROPE GmbH·1 device