92 results
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11ms
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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
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