20 results
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18ms
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Sources: EU EUDAMED, US FDA
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
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
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
HIV1/2 Human Immunodeficiency Virus Rapid Test Device (Whole Blood/Serum/Plasma)
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Assure Tech. (Hangzhou) Co., Ltd.·On the market
SARS-CoV-2 Antigen Rapid Tests for Self-Testing
Device
EU IVDD
·
Eu Ivd Self Testing
·Assure Tech. (Hangzhou) Co., Ltd.·On the market
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
CeCert/077/W/E.1
Certificate
IVDD Annex IV Section 4·Assure Tech. (Hangzhou) Co., Ltd.·CeCert Sp. z o.o.·1 Basic UDI-DI
244409553-200
Certificate
IVDD Annex IV Section 4·Assure Tech. (Hangzhou) Co., Ltd.·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI
HIV Rapid Test Device (Whole blood/Serum/Plasma)
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Assure Tech. (Hangzhou) Co., Ltd.·1 device
SARS-CoV-2 Antigen Rapid Tests for Self-Testing
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Assure Tech. (Hangzhou) Co., Ltd.·1 device