31 results
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16ms
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Sources: EU EUDAMED, US FDA
Fosun Diagnostics (Shanghai) Co., Ltd.
Manufacturer
🇨🇳 China·5 Basic UDI-DIs·5 Devices·CeCert Sp. z o.o.
Labsystems Diagnostics Oy
Manufacturer
🇫🇮 Finland·74 Basic UDI-DIs·75 Devices·Eurofins Electric & Electronics Finland Oy, Eurofins Electric & Electronics Finland Oy, and Eurofins Electric & Electronics Finland Oy
Calpro AS
Manufacturer
🇳🇴 Norway·4 Basic UDI-DIs·4 Devices·Eurofins Electric & Electronics Finland Oy
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.
Biocard™ Celiac Home
Device
EU IVDD
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Eu Ivd Self Testing
·Labsystems Diagnostics Oy·On the market
CalproSmart Self-Test
Device
EU IVDD
·
Eu Ivd Self Testing
·Calpro AS·On the market·15 countries
Biocard™ H pylori IgG Home
Device
EU IVDD
·
Eu Ivd Self Testing
·Labsystems Diagnostics Oy·On the market
Covid-19 Antigen CARD Kit
Device
EU IVDD
·
Eu Ivd Self Testing
·Fosun Diagnostics (Shanghai) Co., Ltd.·On the market
Covid-19 Antigen CARD Kit
Device
EU IVDD
·
Eu Ivd Self Testing
·Fosun Diagnostics (Shanghai) Co., Ltd.·On the market
Covid-19 Antigen CARD Kit
Device
EU IVDD
·
Eu Ivd Self Testing
·Fosun Diagnostics (Shanghai) Co., Ltd.·On the market
ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer
🇨🇳 China·29 Basic UDI-DIs·29 Devices·4 Importers·Sertio Oy, TÜV SÜD Product Service GmbH, POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.
CORONAVIRUS [obsolete from 2025-01-01]
Device
EU IVDD
·
Eu Ivd Self Testing
·Sansure Biotech Inc.·On the market
CORONAVIRUS [obsolete from 2025-01-01]
Device
EU IVDD
·
Eu Ivd Self Testing
·Sansure Biotech Inc.·On the market
CORONAVIRUS [obsolete from 2025-01-01]
Device
EU IVDD
·
Eu Ivd Self Testing
·Sansure Biotech Inc.·On the market
CORONAVIRUS [obsolete from 2025-01-01]
Device
EU IVDD
·
Eu Ivd Self Testing
·Sansure Biotech Inc.·On the market
Calprosmart Self-Test
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Calpro AS·1 device
3-018-200
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Labsystems Diagnostics Oy·1 device
Biocard™ Celiac Home
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Labsystems Diagnostics Oy·1 device
C-02-1172-802-22
Certificate
IVDD Annex III Section 6·Labsystems Diagnostics Oy·Eurofins Electric & Electronics Finland Oy·1 Basic UDI-DI
C-02-1172-804-22
Certificate
IVDD Annex III Section 6·Labsystems Diagnostics Oy·Eurofins Electric & Electronics Finland Oy·1 Basic UDI-DI