967 results · 10ms · 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.

PROG Rapid Quantitative Test (Chemiluminescence Immunoassay)

Device
EU IVDD · Eu Ivd General ·Xiamen Biotime Biotechnology Co., Ltd.·On the market

HL 2135127-1

Certificate
IVDD Annex IV (excluding sections 4, 6)·VivaChek Biotech (Hangzhou) Co., Ltd.·TÜV Rheinland LGA Products GmbH·7 Basic UDI-DIs

CN23/00006997

Certificate
MDR QA·Shenzhen Zijian Biotechnology Co., Ltd·SGS Belgium NV

CeCert/086/W/E.1

Certificate
IVDD Annex III Section 6·Shenzhen Zijian Biotechnology Co., Ltd·CeCert Sp. z o.o.·2 Basic UDI-DIs

Full Automatic Sample Handling System

Device
EU IVDR · Eu Ivd Class A ·Shenzhen Huisong Technology Development Co., Ltd·On the market

Full Automatic Nucleic Acid Extractor

Device
EU IVDR · Eu Ivd Class A ·Shenzhen Huisong Technology Development Co., Ltd·On the market

Product Name Nucleic Acid Extraction Kit

Device
EU IVDR · Eu Ivd Class A ·Shenzhen Huisong Technology Development Co., Ltd·On the market

ORTHODONTIC BRACKETS AND BUTTONS

Device
EU MDR · Eu Md Class 2a ·Zhejiang Risheng Medical Technology Co.,Ltd·On the market·32 countries

SAA and CRP Combo Rapid Test Cassette

Device
EU IVDD · Eu Ivd General ·Hangzhou Alltest Biotech.Co.,Ltd.·On the market

Monkeypox Virus Antigen Test Cassette

Device
EU IVDD · Eu Ivd General ·Hangzhou Alltest Biotech.Co.,Ltd.·On the market

Monkeypox Virus Antibody Rapid Test

Device
EU IVDD · Eu Ivd General ·Hangzhou Alltest Biotech.Co.,Ltd.·On the market

SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test

Device
EU IVDD · Eu Ivd General ·Hangzhou Alltest Biotech.Co.,Ltd.·On the market

COVID-19 Antigen Rapid Test

Device
EU IVDD · Eu Ivd General ·Hangzhou Alltest Biotech.Co.,Ltd.·On the market

Vitamin D Rapid Test Cassette

Device
EU IVDD · Eu Ivd Self Testing ·Hangzhou Alltest Biotech.Co.,Ltd.·On the market

TSH Rapid Test Cassette

Device
EU IVDD · Eu Ivd Self Testing ·Hangzhou Alltest Biotech.Co.,Ltd.·On the market

Ferritin Rapid test cassette

Device
EU IVDD · Eu Ivd Self Testing ·Hangzhou Alltest Biotech.Co.,Ltd.·On the market

FSH Rapid Test Cassette

Device
EU IVDD · Eu Ivd Self Testing ·Hangzhou Alltest Biotech.Co.,Ltd.·On the market

Ovulation (LH) Enhanced Sensitivity Rapid Test Cassette

Device
EU IVDD · Eu Ivd Self Testing ·Hangzhou Alltest Biotech.Co.,Ltd.·On the market

Ovulation (LH) Rapid Test Cassette

Device
EU IVDD · Eu Ivd Self Testing ·Hangzhou Alltest Biotech.Co.,Ltd.·On the market

Pregnancy (hCG) Enhanced Sensitivity Rapid Test Cassette

Device
EU IVDD · Eu Ivd Self Testing ·Hangzhou Alltest Biotech.Co.,Ltd.·On the market