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IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.

Manufacturer
🇹🇷 Türkiye·19 Basic UDI-DIs·19 Devices·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., 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.

Fluorion

Device
EU IVDD · Eu Ivd Annex 2 List A ·IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.·On the market·31 countries

Fluorion

Device
EU IVDD · Eu Ivd Annex 2 List A ·IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.·On the market·31 countries

Fluorion

Device
EU IVDD · Eu Ivd Annex 2 List A ·IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.·On the market·31 countries

Fluorion

Device
EU IVDD · Eu Ivd Annex 2 List A ·IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.·On the market·31 countries

Fluorion HIV-1 QNP 1.1 Real-Time PCR Kit

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.·1 device

Fluorion HDV QNP 1.0 Real-Time PCR Kit

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.·1 device

Fluorion HCV QNP 2.1 Real-Time PCR

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.·1 device

Fluorion HBV QNP 2.0 Real-Time PCR Kit

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.·1 device

1434-IVDD-029/2019

Certificate
IVDD Annex IV Section 4·IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

1434-IVDD-113/2022

Certificate
IVDD Annex IV Section 4·IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

1434-IVDD-152/2018

Certificate
IVDD Annex IV Section 4·IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

1434-IVDD-025/2019

Certificate
IVDD Annex IV Section 4·IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI

Atlas Medical GmbH

Manufacturer
🇩🇪 Germany·179 Basic UDI-DIs·179 Devices·GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, and GMED SAS

Beckman Coulter Inc.

Manufacturer
🇺🇸 United States·975 Basic UDI-DIs·1166 Devices·17 Importers·BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, GMED SAS, and GMED SAS

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

GENOTROPY

Manufacturer
🇫🇷 France·10 Basic UDI-DIs·10 Devices·BSI Group The Netherlands B.V. and BSI Group The Netherlands B.V.

HIV 1 / 2 - RT & POC

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

ABO Set (Anti-A (1/512), Anti-B (1/512), Anti-AB (1/512) Anti-D (1/128)), 4x10ml, 4vials/Plastic Pack

Device
EU IVDD · Eu Ivd Annex 2 List A ·Atlas Medical GmbH·On the market

ABO Set (Anti-A (1/512), Anti-B (1/512), Anti-AB (1/512) Anti-D (1/128)), 4x10ml/Plastic Pack

Device
EU IVDD · Eu Ivd Annex 2 List A ·Atlas Medical GmbH·On the market