74 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.

CEA FIA

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

CEA Rapid Quantitative Test

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

Carcinoembryonic Antigen Kit (CEA)(CLIA)

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

CEA/AFP Rapid Quantitative Test

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

CEA Rapid Quantitative Test (Chemiluminescence Immunoassay)

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

CEA Rapid Quantitative Test (Chemiluminescence Immunoassay)

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

CEA Rapid Quantitative Test (Chemiluminescence Immunoassay)

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

CEA Rapid Quantitative Test (Chemiluminescence Immunoassay)

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

CEA Rapid Quantitative Test (Chemiluminescence Immunoassay)

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

Assure Tech. (Hangzhou) Co., Ltd.

Manufacturer
🇨🇳 China·212 Basic UDI-DIs·212 Devices·2 Importers·TÜV Rheinland LGA Products GmbH, CeCert Sp. z o.o., TÜV Rheinland LGA Products GmbH, 3EC International a.s., TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, CeCert Sp. z o.o., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., and TÜV Rheinland LGA Products GmbH

W.H.P.M. Bioresearch & Technology Co., Ltd.

Manufacturer
🇨🇳 China·27 Basic UDI-DIs·27 Devices·7 Importers·TÜV Rheinland LGA Products GmbH

Carcinoembryonic Antigen Kit (CEA) (Latex-Enhanced Immunoturbidimetric Method)

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

Hangzhou Laihe Biotech Co., Ltd.

Manufacturer
🇨🇳 China·6 Basic UDI-DIs·6 Devices·2 Importers·CeCert Sp. z o.o. and TÜV Rheinland LGA Products GmbH

CORONAVIRUS - NA REAGENTS [obsolete from 2025-01-01]

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

One-Step Drug of Abuse Test Tricyclic Antidepressants (TCA)

Device
EU IVDD · Eu Ivd Self Testing ·W.H.P.M. Bioresearch & Technology Co., Ltd.·On the market

One-Step Drug of Abuse Test -Methylenedioxymethamphetamine (MDMA)

Device
EU IVDD · Eu Ivd Self Testing ·W.H.P.M. Bioresearch & Technology Co., Ltd.·On the market

One-Step Drug Of Abuse Test 2-Ethylidene-1,5-dimethyl-3,3-dipheylpyrrolidine (EDDP)

Device
EU IVDD · Eu Ivd Self Testing ·W.H.P.M. Bioresearch & Technology Co., Ltd.·On the market

One-Step Drug Of Abuse Test -Morphine (MOR)

Device
EU IVDD · Eu Ivd Self Testing ·W.H.P.M. Bioresearch & Technology Co., Ltd.·On the market

One-Step Drug Of Abuse Test -Buprenorphine (BUP)

Device
EU IVDD · Eu Ivd Self Testing ·W.H.P.M. Bioresearch & Technology Co., Ltd.·On the market

One-Step Drug Of Abuse Test Barbiturates (BARB)

Device
EU IVDD · Eu Ivd Self Testing ·W.H.P.M. Bioresearch & Technology Co., Ltd.·On the market