140 results
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11ms
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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.
Shenzhen Superbio Technology Co.,Ltd.
Manufacturer
🇨🇳 China·589 Basic UDI-DIs·591 Devices·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
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
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.
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
2019-nCoV Antigen Rapid Test (Immunochromatography Assay)
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Shenzhen Superbio Technology Co.,Ltd.·1 device
2019-nCoV Antigen Rapid Test (Immunochromatography Assay)
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Shenzhen Superbio Technology Co.,Ltd.·1 device
2019-nCoV Antigen Rapid Test (Immunochromatography Assay)
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Shenzhen Superbio Technology Co.,Ltd.·1 device
TRUD
Device
EU MDD
·
Eu Md Class 2a
·MDT Int'l SA·On the market·4 countries
GAF
Device
EU MDD
·
Eu Md Class 3
·MDT Int'l SA·On the market·2 countries
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
1434-IVDD-199/2022
Certificate
IVDD Annex IV (excluding sections 4, 6)·Sanway Gene Tech. Inc.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI
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
Merlin Biomedical (Xiamen) Co., Ltd.
Manufacturer
🇨🇳 China·1 Basic UDI-DI·1 Device·CeCert Sp. z o.o.
QPZ-01910-18
Certificate
MDD Annex V·MDT Int'l SA·ISTITUTO SUPERIORE DI SANITA'·1 Basic UDI-DI
QCT-0176-21
Certificate
MDD Annex II (excluding section 4)·MDT Int'l SA·ISTITUTO SUPERIORE DI SANITA'·1 Basic UDI-DI
TRUD
Basic UDI-DI
EU MDD
·
Eu Md Class 2a
·MDT Int'l SA·1 device