258 results
·
10ms
·
Sources: EU EUDAMED, US FDA
Sanway Gene Tech. Inc.
Manufacturer
🇨🇳 China·1 Basic UDI-DI·1 Device·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.
Sansure Biotech Inc.
Manufacturer
🇨🇳 China·1252 Basic UDI-DIs·1376 Devices·4 Importers·TÜV SÜD Product Service GmbH, CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.
HBV / HCV / HIV COMBINATION - MULTIPLEX NA REAGENTS
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Sanway Gene Tech. Inc.·On the market·3 countries
Hepatitis B Virus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Sansure Biotech Inc.·On the market
Hepatitis C Virus RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Sansure Biotech Inc.·On the market·3 countries
Human Immunodeficiency Virus Type 1 RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Sansure Biotech Inc.·On the market
GENOTROPY
Manufacturer
🇫🇷 France·10 Basic UDI-DIs·10 Devices·BSI Group The Netherlands B.V. and BSI Group The Netherlands B.V.
ANTITOXIN GmbH
Manufacturer
🇩🇪 Germany·86 Basic UDI-DIs·97 Devices·MDC MEDICAL DEVICE CERTIFICATION GMBH, MDC MEDICAL DEVICE CERTIFICATION GMBH, MDC MEDICAL DEVICE CERTIFICATION GMBH, MDC MEDICAL DEVICE CERTIFICATION GMBH, and MDC MEDICAL DEVICE CERTIFICATION GMBH
DiaMex GmbH
Manufacturer
🇩🇪 Germany·23 Basic UDI-DIs·42 Devices·MDC MEDICAL DEVICE CERTIFICATION GMBH and MDC MEDICAL DEVICE CERTIFICATION GMBH
Jiangxi Aicare Medical Technology Co.,Ltd
Manufacturer
🇨🇳 China·3 Basic UDI-DIs·3 Devices·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH
Tianjin HUAC Healthcare Technology Co., Ltd.
Manufacturer
🇨🇳 China·3 Basic UDI-DIs·3 Devices·TÜV Rheinland LGA Products GmbH
Vela Operations Singapore Pte. Ltd.
Manufacturer
🇸🇬 Singapore·75 Basic UDI-DIs·82 Devices·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH
Abon Biopharm(Hangzhou) Co., Ltd
Manufacturer
🇨🇳 China·123 Basic UDI-DIs·123 Devices·1 Importer·TÜV SÜD Product Service GmbH, 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, GMED SAS, and GMED SAS
General Biologicals Corporation
Manufacturer
🇹🇼 Taiwan·13 Basic UDI-DIs·13 Devices·DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., DEKRA Certification B.V., and DEKRA Certification B.V.
AB Diagnostic Systems GmbH
Manufacturer
🇩🇪 Germany·2 Basic UDI-DIs·2 Devices·MDC MEDICAL DEVICE CERTIFICATION GMBH
Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH
Manufacturer
🇩🇪 Germany·15 Basic UDI-DIs·15 Devices·MDC MEDICAL DEVICE CERTIFICATION GMBH, MDC MEDICAL DEVICE CERTIFICATION GMBH, MDC MEDICAL DEVICE CERTIFICATION GMBH, MDC MEDICAL DEVICE CERTIFICATION GMBH, and MDC MEDICAL DEVICE CERTIFICATION GMBH
MP Biomedicals Asia Pacific Pte Ltd
Manufacturer
🇸🇬 Singapore·9 Basic UDI-DIs·9 Devices·bqs. s.r.o., bqs. s.r.o., bqs. s.r.o., and TÜV SÜD Product Service GmbH
Nucleic Acid Test Kit for HBV, HCV, HIV (Type1+2) (Real-time PCR)
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Sanway Gene Tech. Inc.·1 device
1434-IVDD-198/2022
Certificate
IVDD Annex IV Section 4·Sanway Gene Tech. Inc.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI
Atlas Medical GmbH
Manufacturer
🇩🇪 Germany·179 Basic UDI-DIs·179 Devices·GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, and GMED SAS