339 results · 17ms · Sources: EU EUDAMED, US FDA

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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

Atomo Diagnostics Limited

Manufacturer
🇦🇺 Australia·2 Basic UDI-DIs·2 Devices·BSI Group The Netherlands B.V. and BSI Group The Netherlands B.V.

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

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.

bioLytical Laboratories Inc.

Manufacturer
🇨🇦 Canada·38 Basic UDI-DIs·38 Devices·Presafe Denmark A/S, Presafe Denmark A/S, Presafe Denmark A/S, Presafe Denmark A/S, and Presafe Denmark A/S

Assure Tech. (Hangzhou) Co., Ltd.

Manufacturer
🇨🇳 China·212 Basic UDI-DIs·212 Devices·2 Importers·TÜV Rheinland LGA Products GmbH, CeCert Sp. z o.o., TÜV Rheinland LGA Products GmbH, 3EC International a.s., TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, CeCert Sp. z o.o., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., and TÜV Rheinland LGA Products 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

Simplitude ByMe

Device
EU IVDD · Eu Ivd Annex 2 List A ·Atomo Diagnostics Limited·On the market·7 countries

Simplitude ByMe

Device
EU IVDD · Eu Ivd Annex 2 List A ·Atomo Diagnostics Limited·On the market·7 countries

HBSAG - RT & POC

Device
EU IVDD · Eu Ivd Annex 2 List A ·Abon Biopharm(Hangzhou) Co., Ltd·On the market

HCV ANTIBODY -RT & POC

Device
EU IVDD · Eu Ivd Annex 2 List A ·Abon Biopharm(Hangzhou) Co., Ltd·On the market

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

HIV 1 / 2 - RT & POC

Device
EU IVDD · Eu Ivd Annex 2 List A ·Abon Biopharm(Hangzhou) Co., Ltd·On the market