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08693285181292

Anti-HCV Test

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285181292
Basic UDI-DI: B-08693285181292
Reference: IHC01
EMDN: W0105090202
EMDN description: HCV ANTIBODY -RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:26

Manufacturer products View details

08693285181285

Anti-HBs Test

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285181285
Basic UDI-DI: B-08693285181285
Reference: IHB01
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:26

Manufacturer products View details

08693285181278

HBsAg Test

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285181278
Basic UDI-DI: B-08693285181278
Reference: IHB03
EMDN: W0105090201
EMDN description: HBSAG - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:26

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08693285181179

Anti-HCV Test

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285181179
Basic UDI-DI: B-08693285181179
Reference: RTHC01
EMDN: W0105090202
EMDN description: HCV ANTIBODY -RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:25

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08693285181162

Anti-HBs Test

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285181162
Basic UDI-DI: B-08693285181162
Reference: RTHB01
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:25

Manufacturer products View details

08693285181155

HBsAg Test

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285181155
Basic UDI-DI: B-08693285181155
Reference: RTHB03
EMDN: W0105090201
EMDN description: HBSAG - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:25

Manufacturer products View details

08693285181056

Anti-HCV Test

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285181056
Basic UDI-DI: B-08693285181056
Reference: THC01
EMDN: W0105090202
EMDN description: HCV ANTIBODY -RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:25

Manufacturer products View details

08693285181049

Anti-HBs Test

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285181049
Basic UDI-DI: B-08693285181049
Reference: THB01
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:25

Manufacturer products View details

08693285181032

HBsAg Test

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.
Manufacturer SRN: TR-MF-000028553
UDI-DI: 08693285181032
Basic UDI-DI: B-08693285181032
Reference: THB03
EMDN: W0105090201
EMDN description: HBSAG - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:25

Manufacturer products View details

Prueba Rápida de HBsAg en Casete

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 08436592551378
Basic UDI-DI: B-08436592551378
Reference: IHBSG-402
EMDN: W0105090201
EMDN description: HBSAG - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 08.07.2026 00:51

Manufacturer products Authorised representative products Authorised representative actors View details

HCV Hepatitis C Virus Rapid Test (Serum/Plasma)(Cassette)

GCHCV-302a

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00816490028482
Basic UDI-DI: B-00816490028482
Reference: GCHCV-302a
EMDN: W0105090202
EMDN description: HCV ANTIBODY -RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 04.07.2026 21:39

Manufacturer products Authorised representative products Authorised representative actors View details

HCV Hepatitis C Virus Rapid Test (Serum/Plasma)(Cassette)

GCHCV-402a

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: 00816490028475
Basic UDI-DI: B-00816490028475
Reference: GCHCV-402a
EMDN: W0105090202
EMDN description: HCV ANTIBODY -RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 04.07.2026 21:39

Manufacturer products Authorised representative products Authorised representative actors View details

Artron Hepatitis C Virus (HCV) Antibody Test

cassette

IVD Annex II List AIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347560973
Basic UDI-DI: B-00628347560973
Reference: A02-06-222
EMDN: W0105090202
EMDN description: HCV ANTIBODY -RT & POC
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

Artron Hepatitis B Virus Surface Antigen (HBsAg) Test

Cassette

IVD Annex II List AIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347560874
Basic UDI-DI: B-00628347560874
Reference: A02-01-222
EMDN: W0105090201
EMDN description: HBSAG - RT & POC
First on market country: Romania
Authorised representative: MedNet EC-REP GmbH
Last updated: 04.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

OraQuick HCV Rapid Antibody Test

3001-2141

IVD Annex II List AIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingSingle use

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 00608337000566
Basic UDI-DI: B-00608337000566
Reference: 3001-2141
EMDN: W0105090202
EMDN description: HCV ANTIBODY -RT & POC
First on market country: Austria
Authorised representative: QbD RepS BV
Last updated: 04.07.2026 17:19

Manufacturer products Authorised representative products Authorised representative actors View details

OraQuick® HCV Rapid Antibody Test Kit Controls

1001-0278

IVD Annex II List AIVDDOn the marketHuman tissuesNear-patient testingProfessional testing

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 00608337000528
Basic UDI-DI: B-00608337000528
Reference: 1001-0278
EMDN: W0105090202
EMDN description: HCV ANTIBODY -RT & POC
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 04.07.2026 17:19

Manufacturer products Authorised representative products Authorised representative actors View details

ABON™

IHBsg-402001

IVD Class DIVDR 2017/746Not intended for EU marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Abon Biopharm(Hangzhou) Co., Ltd
Manufacturer SRN: CN-MF-000009171
UDI-DI: 06952999410008
Basic UDI-DI: 69529994HBV0001X4
Reference: IHBsg-402001
EMDN: W0105090201
EMDN description: HBSAG - RT & POC
First on market country: -
Safety summary (SSCP/SSP): IVDRTF-0010 CH7.4 · Rev. 4
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 02.07.2026 10:54

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Artron Hepatitis C Virus (HCV) Antibody Test

Cassette

IVD Class DIVDR 2017/746On the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347560980
Basic UDI-DI: 62834756AL0206026S
Reference: A02-06-322P25
EMDN: W0105090202
EMDN description: HCV ANTIBODY -RT & POC
First on market country: Romania
Safety summary (SSCP/SSP): AR-SSP-HCV Ab (WB)-2024 · Rev. 1
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 08:32

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Artron Hepatitis B Surface Antigen (HBsAg) Test

Cassette

IVD Class DIVDR 2017/746On the marketKitNear-patient testingProfessional testingSingle use

Manufacturer: Artron Laboratories Inc.
Manufacturer SRN: CA-MF-000028974
UDI-DI: 00628347560881
Basic UDI-DI: 62834756AL0201025Z
Reference: A02-01-322P25
EMDN: W0105090201
EMDN description: HBSAG - RT & POC
First on market country: Romania
Safety summary (SSCP/SSP): AR-SSP-HBsAg-2024 · Rev. 1
Authorised representative: MedNet EC-REP GmbH
Last updated: 02.07.2026 08:32

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Accu-Tell® HEV IgM Cassette(Serum/Plasma)

Cassette

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: 06970581430609
Basic UDI-DI: B-06970581430609
Reference: ABT-IDT-B246
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 30.06.2026 05:42

Manufacturer products Authorised representative products Authorised representative actors View details