35 results
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8ms
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Sources: EU EUDAMED, US FDA
InTec PRODUCTS, INC.
Manufacturer
🇨🇳 China·25 Basic UDI-DIs·25 Devices·2 Importers·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH
Abbott Diagnostics Medical Co., Ltd.
Manufacturer
🇯🇵 Japan·4 Basic UDI-DIs·4 Devices·1 Importer·TÜV SÜD Product Service GmbH and TÜV SÜD Product Service GmbH
MP Biomedicals Asia Pacific Pte Ltd
Manufacturer
🇸🇬 Singapore·9 Basic UDI-DIs·9 Devices·bqs. s.r.o., bqs. s.r.o., bqs. s.r.o., and TÜV SÜD Product Service GmbH
HIV MULTIPLE ANTIBODY
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·InTec PRODUCTS, INC.·No longer on the market
HCV ANTIBODY (TOTAL)
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·InTec PRODUCTS, INC.·No longer on the market
HCV ANTIBODY (TOTAL)
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·InTec PRODUCTS, INC.·On the market
HCV ANTIBODY (TOTAL)
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·InTec PRODUCTS, INC.·No longer on the market
HIV MULTIPLE ANTIBODY
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·InTec PRODUCTS, INC.·On the market
HIV MULTIPLE ANTIBODY
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·InTec PRODUCTS, INC.·On the market
HIV MULTIPLE ANTIBODY
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·InTec PRODUCTS, INC.·No longer on the market
HCV ANTIBODY (TOTAL)
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·InTec PRODUCTS, INC.·On the market
Determine
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Abbott Diagnostics Medical Co., Ltd.·On the market
HIV AG/AB COMBI - RT & POC
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Abbott Diagnostics Medical Co., Ltd.·On the market·15 countries
MP Diagnostics HIV Blot 2.2
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·MP Biomedicals Asia Pacific Pte Ltd·On the market
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.
Abon Biopharm(Hangzhou) Co., Ltd
Manufacturer
🇨🇳 China·123 Basic UDI-DIs·123 Devices·1 Importer·TÜV SÜD Product Service GmbH, INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, GMED SAS, and GMED SAS
TÜV SÜD Product Service GmbH
Notified body
🇩🇪 Germany·628 Manufacturers·12418 Basic UDI-DIs
Determine HIV Early Detect
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Abbott Diagnostics Medical Co., Ltd.·1 device
ONE STEP Anti-HIV (1&2) Test
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·InTec PRODUCTS, INC.·1 device
ONE STEP Anti-HIV (1&2) Test
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·InTec PRODUCTS, INC.·1 device