33 results
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9ms
·
Sources: EU EUDAMED, US FDA
MCR-1 Enzyme Rapid Test
Device
EU IVDD
·
Eu Ivd General
·Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.·On the market
MCR-1 Enzyme Rapid Test
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.·1 device
Xcellance Medical Technologies Pvt. Ltd.
Manufacturer
🇮🇳 India
Human BCR-ABL Fusion Gene Mutation Detection Kit (Fluorescence PCR)
Device
EU IVDD
·
Eu Ivd General
·Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.·On the market
BIO-VIM
Device
EU MDR
·
Eu Md Class 3
·Chetan Meditech Pvt. Ltd.·On the market·2 countries
BIOTEK, BIO-VIM, BIO-VIM LRP, BIO-VIM LRT, ARTHROVIMS BR Anchor
Basic UDI-DI
EU MDR
·
Eu Md Class 3
·Chetan Meditech Pvt. Ltd.·1 device
Chetan Meditech Pvt. Ltd.
Manufacturer
🇮🇳 India·4 Importers·3EC International a.s., 3EC International a.s., 3EC International a.s., 3EC International a.s., 3EC International a.s., and 3EC International a.s.
Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.
Manufacturer
🇨🇳 China·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH
Human BCR-ABL Fusion Gene Mutation Detection Kit (Fluorescence PCR)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.·1 device
Shanghai Shenqi Medical Technology Co., Ltd.
Manufacturer
🇨🇳 China·1 Basic UDI-DI·12 Devices·UDEM Adriatic d.o.o.
Goodwood Medical Care Ltd.
Manufacturer
🇨🇳 China·8 Importers·TÜV Rheinland LGA Products GmbH
DAE MYUNG CHEMICAL CO., LTD. (VIETNAM)
Manufacturer
🇻🇳 Vietnam·TÜV Rheinland LGA Products GmbH
SARS-CoV-2 & Influenza AB Antigen Combo Rapid Test Kit (LFIA)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Zhejiang Wantaifu Biotechnology Co., Ltd·1 device
FLU A & B & SARS-Cov-2 & RSV& ADV Combo Rapid Test Device
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Zhejiang Wantaifu Biotechnology Co., Ltd·1 device
Dengue IgG/IgM and NS1 Rapid Test Device
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Zhejiang Wantaifu Biotechnology Co., Ltd·1 device
Dengue IgG/IgM and NS1 Rapid Test Device
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Zhejiang Wantaifu Biotechnology Co., Ltd·1 device
Shenzhen Zijian Biotechnology Co., Ltd
Manufacturer
🇨🇳 China·287 Basic UDI-DIs·368 Devices·SGS Belgium NV and CeCert Sp. z o.o.
Chetan Meditech Pvt. Ltd.
Manufacturer
🇮🇳 India·11 Basic UDI-DIs·11 Devices·5 Importers·3EC International a.s., 3EC International a.s., and 3EC International a.s.
Takagi seiko
Manufacturer
🇯🇵 Japan·14 Basic UDI-DIs·29 Devices·4 Importers·SGS Belgium NV, SGS FIMKO OY, SGS FIMKO OY, and SGS FIMKO OY
HZ 2113818-1
Certificate
MDR QMS·Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.·TÜV Rheinland LGA Products GmbH