132 results
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8ms
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Sources: EU EUDAMED, US FDA
Shenzhen Superbio Technology Co.,Ltd.
Manufacturer
🇨🇳 China·589 Basic UDI-DIs·591 Devices·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.
Merlin Biomedical (Xiamen) Co., Ltd.
Manufacturer
🇨🇳 China·1 Basic UDI-DI·1 Device·CeCert Sp. z o.o.
MDT Int'l SA
Manufacturer
🇨🇭 Switzerland·7 Basic UDI-DIs·7 Devices·1 Importer·ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', DEKRA Certification B.V., and DEKRA Certification B.V.
BPR Medical Limited
Manufacturer
44 Basic UDI-DIs·44 Devices·3 Importers·SGS Belgium NV
Yelatma Instrument-Making Enterprise Joint-Stock Company
Manufacturer
🇷🇺 Russian Federation·9 Basic UDI-DIs·20 Devices·TÜV NORD CERT GmbH
1434-IVDD-254/2022
Certificate
IVDD Annex III Section 6·Shenzhen Superbio Technology Co.,Ltd.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·3 Basic UDI-DIs
CeCert/037/W/E.1
Certificate
IVDD Annex III Section 6·Merlin Biomedical (Xiamen) Co., Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI
2116232DE01
Certificate
MDD Annex II Section 4·MDT Int'l SA·DEKRA Certification B.V.·3 Basic UDI-DIs
2116232DE02
Certificate
MDD Annex II Section 4·MDT Int'l SA·DEKRA Certification B.V.·2 Basic UDI-DIs
GB19/964430
Certificate
MDD Annex II (excluding section 4)·BPR Medical Limited·SGS Belgium NV·44 Basic UDI-DIs
44232117836
Certificate
MDD Annex II (excluding section 4)·Yelatma Instrument-Making Enterprise Joint-Stock Company·TÜV NORD CERT GmbH·6 Basic UDI-DIs
QCT-0176-21
Certificate
MDD Annex II (excluding section 4)·MDT Int'l SA·ISTITUTO SUPERIORE DI SANITA'·1 Basic UDI-DI
2019-nCoV Antigen Rapid Test (Immunochromatography Assay)
Device
EU IVDD
·
Eu Ivd Self Testing
·Shenzhen Superbio Technology Co.,Ltd.·On the market
2019-nCoV Antigen Rapid Test (Immunochromatography Assay)
Device
EU IVDD
·
Eu Ivd Self Testing
·Shenzhen Superbio Technology Co.,Ltd.·On the market
2019-nCoV Antigen Rapid Test (Immunochromatography Assay)
Device
EU IVDD
·
Eu Ivd Self Testing
·Shenzhen Superbio Technology Co.,Ltd.·On the market
SARS-CoV-2 Antigen Rapid Test Cassette
Device
EU IVDD
·
Eu Ivd Self Testing
·Merlin Biomedical (Xiamen) Co., Ltd.·On the market
TendoVis
Device
EU MDD
·
Eu Md Class 3
·MDT Int'l SA·On the market·10 countries
SportVis
Device
EU MDD
·
Eu Md Class 3
·MDT Int'l SA·On the market·1 country
DualVis
Device
EU MDD
·
Eu Md Class 3
·MDT Int'l SA·On the market·1 country
RenehaVis
Device
EU MDD
·
Eu Md Class 3
·MDT Int'l SA·On the market·10 countries