93 results
·
8ms
·
Sources: EU EUDAMED, US FDA
Daan Gene Co., Ltd.
Manufacturer
🇨🇳 China·127 Basic UDI-DIs·194 Devices·CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., CeCert Sp. z o.o., and CeCert Sp. z o.o.
Benzodiazepine(BZO) Rapid Test
Device
EU IVDD
·
Eu Ivd General
·VivaChek Biotech (Hangzhou) Co., Ltd.·On the market
Benzodiazepine(BZO) Rapid Test
Device
EU IVDD
·
Eu Ivd General
·VivaChek Biotech (Hangzhou) Co., Ltd.·On the market
Hangzhou Realy Tech Co.,Ltd.
Manufacturer
🇨🇳 China·128 Basic UDI-DIs·129 Devices·CeCert Sp. z o.o., CeCert Sp. z o.o., and CeCert Sp. z o.o.
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.
Benzodiazepine (BZO) Rapid Test(Urine)
Device
EU IVDD
·
Eu Ivd General
·Xiamen Biotime Biotechnology Co., Ltd.·On the market
Benzodiazepine (BZO) Assay Reagent Kit (CMIA)
Device
EU IVDD
·
Eu Ivd General
·Hangzhou Realy Tech Co.,Ltd.·On the market
Dynamiker Biotechnology (Tianjin) Co., Ltd.
Manufacturer
🇨🇳 China·192 Basic UDI-DIs·192 Devices·1 Importer·CeCert Sp. z o.o.
Suny (Xiamen) Biotechnology Co., Ltd.
Manufacturer
🇨🇳 China·2 Basic UDI-DIs·2 Devices·1 Importer·CeCert Sp. z o.o.
BZO Rapid Test Kit (Colloidal gold method)
Device
EU IVDD
·
Eu Ivd General
·Nanjing Synthgene Medical Technology Co., Ltd. ·On the market
Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer
🇨🇳 China·287 Basic UDI-DIs·368 Devices·SGS Belgium NV and CeCert Sp. z o.o.
One-Step Drug Of Abuse Test -Benzodiazepine (BZO)
Device
EU IVDD
·
Eu Ivd Self Testing
·W.H.P.M. Bioresearch & Technology Co., Ltd.·On the market
BAR/BZO/MOP Rapid Test Kit (Colloidal gold method)
Device
EU IVDD
·
Eu Ivd General
·Nanjing Synthgene Medical Technology Co., Ltd. ·On the market
Zhongshan Bio-Tech Co., Ltd.
Manufacturer
🇨🇳 China·24 Basic UDI-DIs·24 Devices·CeCert Sp. z o.o. and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.
Oral Fluid Multi-Panel Drug Test Kit (THC/AMP/ OPI/MET/COC /BZO)
Device
EU IVDD
·
Eu Ivd General
·Hangzhou Immuno Biotech Co., Ltd·On the market
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
Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer
🇨🇳 China·119 Basic UDI-DIs·171 Devices·32 Importers·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., CeCert Sp. z o.o., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., CeCert Sp. z o.o., TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH
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