16 results
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9ms
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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.
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
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
HCV ANTIBODY -RT & POC
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Abon Biopharm(Hangzhou) Co., Ltd·On the market
HBSAG - RT & POC
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Abon Biopharm(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
HCV Hepatitis C Virus Rapid Test Device (Serum/Plasma)
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Abon Biopharm(Hangzhou) Co., Ltd·1 device
HBsAg Hepatitis B Surface Antigen Rapid Test Device (Whole Blood/Serum/Plasma)
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Abon Biopharm(Hangzhou) Co., Ltd·1 device
No. 11 0498 CN/NB
Certificate
IVDD Annex IV Section 4·Abon Biopharm(Hangzhou) Co., Ltd·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390·2 Basic UDI-DIs
INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390
Notified body
🇨🇿 Czechia·16 Manufacturers·135 Basic UDI-DIs