OBE - BEUDAMED

Koru Pharma Co., Ltd

Manufacturer

🇰🇷 South Korea

Tianjin Demax Medical Technology Co., Ltd.

Manufacturer

🇨🇳 China

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLICOR HEPATITIS C VIRUS (HCV) TEST, V2.0

Lunit Inc.

Manufacturer

🇰🇷 South Korea·2 Basic UDI-DIs·5 Devices·3 Importers

Nanjing Vazyme Medical Technology Co.,Ltd.

Manufacturer

🇨🇳 China·22 Basic UDI-DIs·29 Devices·1 Importer

Obelis s.a.

Authorized representative

🇧🇪 Belgium·546 Manufacturers·18515 Devices

Aptiva® CTD Essential Reagent

FDA UDI

INOVA DIAGNOSTICS, INC.·08430793040051·1. Aptiva CTD Essential Reagent Cartridge: a. ...

BL Tech

Manufacturer

🇰🇷 South Korea

Hangzhou Singclean Medical Products Co., Ltd.

Manufacturer

🇨🇳 China·149 Basic UDI-DIs·149 Devices·3 Importers·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş., UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş., UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş., and UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.

Anti-Ss-A 52 Autoantibodies

FDA classification

FDA Class 2 ·Anti-Ss-A 52 Autoantibodies

Changsha Sinocare Inc.

Manufacturer

🇨🇳 China·67 Basic UDI-DIs·68 Devices·1 Importer·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

Changsha Sinocare Inc.

Manufacturer

🇨🇳 China·1 Importer·TÜV Rheinland LGA Products GmbH