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228 device results listed.

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HCV Rapid Test

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-06936983106009W4
Basic UDI-DI: B-06936983106009W4
Reference: IHC-402
EMDN: W0105020303
EMDN description: HCV ANTIBODY (TOTAL)
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 06.07.2026 11:24

Manufacturer products Authorised representative products Authorised representative actors View details

PoET HBV

IVD Annex II List AIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH
Manufacturer SRN: DE-MF-000025295
UDI-DI: 04262353370049
Basic UDI-DI: B-04262353370049
Reference: P2B-28-30
EMDN: W0105020216
EMDN description: HEPATITIS B VIRUS - NA REAGENTS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 07:54

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INSTI HCV ANTIBODY TEST

90-1062-005 and 90-1062-006

IVD Annex II List AIVDDOn the marketKitNear-patient testingProfessional testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597200704
Basic UDI-DI: B-00686597200704
Reference: 90-1062-005 and 90-1062-006
EMDN: W0105020303
EMDN description: HCV ANTIBODY (TOTAL)
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 18:04

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INSTI HCV ANTIBODY TEST

90-1062-001, 90-1062-002, 90-1062-003

IVD Annex II List AIVDDOn the marketKitNear-patient testingProfessional testingSingle use

Manufacturer: bioLytical Laboratories Inc.
Manufacturer SRN: CA-MF-000023304
UDI-DI: 00686597200674
Basic UDI-DI: B-00686597200674
Reference: 90-1062-001, 90-1062-002, and 90-1062-003
EMDN: W0105020303
EMDN description: HCV ANTIBODY (TOTAL)
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 04.07.2026 18:04

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MERISCREEN HCV

RPDHCV-01 RPDHCV-03

IVD Class DIVDR 2017/746On the marketDirect markingKitProfessional testingSingle use

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 18906074563610
Basic UDI-DI: 8905459MHCVRT9A
Reference: RPDHCV-01 RPDHCV-03
EMDN: W0105020303
EMDN description: HCV ANTIBODY (TOTAL)
First on market country: Germany
Safety summary (SSCP/SSP): CE-SSP/IM/CLD/019 · Rev. 00
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 21:38

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MERISCREEN

RPDHBV-01 RPDHBV-03

IVD Class DIVDR 2017/746On the marketDirect markingKitProfessional testingSingle use

Manufacturer: Meril Diagnostics Pvt. Ltd.
Manufacturer SRN: IN-MF-000028158
UDI-DI: 18906074563603
Basic UDI-DI: 8905459MHBSAGRTG4
Reference: RPDHBV-01 RPDHBV-03
EMDN: W0105020201
EMDN description: HEPATITIS B SURFACE ANTIGEN
First on market country: Türkiye
Safety summary (SSCP/SSP): CE-SSP/IM/CLD/018 · Rev. 00
Authorised representative: Obelis s.a.
Last updated: 03.07.2026 21:38

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GENERIC HBV VIRAL LOAD VER 2.0

IVD Class DIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Hain Lifescience GmbH
Manufacturer SRN: DE-MF-000008606
UDI-DI: 04049055003891
Basic UDI-DI: 40490550300001100TU
Reference: TR004.2-250IC
EMDN: W0105020216
EMDN description: HEPATITIS B VIRUS - NA REAGENTS
First on market country: France
Safety summary (SSCP/SSP): TR004.2-250IC · Rev. 3
Authorised representative: -
Last updated: 01.07.2026 18:48

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Access anti-HAV IgM

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590745127
Basic UDI-DI: 150995901C39447SC
Reference: C39447
EMDN: W0105020102
EMDN description: HAV ANTIBODY (TOTAL)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:39

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Access anti-HAV

C39444

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590745097
Basic UDI-DI: 150995901C39444S6
Reference: C39444
EMDN: W0105020102
EMDN description: HAV ANTIBODY (TOTAL)
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 01.07.2026 11:39

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LyoSens HEV qPCR Kit

HEV qPCR Kit

IVD Class CIVDR 2017/746On the marketInstrumentKitProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685115805478
Basic UDI-DI: 868511580PCR43JC
Reference: PCR43
EMDN: W0105020507
EMDN description: HEPATITIS E VIRUS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 30.06.2026 23:36

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ChainFor HEV qPCR Kit

HEV qPCR Kit

IVD Class CIVDR 2017/746On the marketInstrumentKitProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595033456
Basic UDI-DI: 868511580PCR43JC
Reference: PCR43
EMDN: W0105020507
EMDN description: HEPATITIS E VIRUS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 30.06.2026 23:30

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08033629923902

GEN-C Real Time

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Nuclear Laser Medicine srl
Manufacturer SRN: IT-MF-000025709
UDI-DI: 08033629923902
Basic UDI-DI: 803362992GENHCVRT3H
Reference: AA1441/48
EMDN: W0105020309
EMDN description: HEPATITIS C VIRUS (HCV) GENOTYPING - NA REAGENTS
First on market country: Italy
Authorised representative: -
Last updated: 30.06.2026 13:39

Manufacturer products View details

06970301452690

Rapid Test for IgM Antibody to Hepatitis A Virus (Colloidal Gold Device)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Manufacturer SRN: CN-MF-000040626
UDI-DI: 06970301452690
Basic UDI-DI: B-06970301452690
Reference: WJ-1050
EMDN: W0105020104
EMDN description: HAV ANTIBODY IGM
First on market country: Romania
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 01:26

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06970301452560

Rapid Test for IgM Antibody to Hepatitis E Virus (Colloidal Gold Device)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Manufacturer SRN: CN-MF-000040626
UDI-DI: 06970301452560
Basic UDI-DI: B-06970301452560
Reference: WE-1510
EMDN: W0105020505
EMDN description: HEV ANTIBODY IGM
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 01:26

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06970301452553

Rapid Test for IgM Antibody to Hepatitis A Virus (Colloidal Gold Device)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Manufacturer SRN: CN-MF-000040626
UDI-DI: 06970301452553
Basic UDI-DI: B-06970301452553
Reference: WJ-1010
EMDN: W0105020104
EMDN description: HAV ANTIBODY IGM
First on market country: Romania
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 01:26

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06970301452546

WANTAI HEV-Ag ELISA Plus

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Manufacturer SRN: CN-MF-000040626
UDI-DI: 06970301452546
Basic UDI-DI: B-06970301452546
Reference: WE-7596
EMDN: W0105020501
EMDN description: HEV ANTIGEN
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 01:26

Manufacturer products Authorised representative products Authorised representative actors View details

06970301452539

WANTAI HEV-IgG ELISA

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Manufacturer SRN: CN-MF-000040626
UDI-DI: 06970301452539
Basic UDI-DI: B-06970301452539
Reference: WE-7296
EMDN: W0105020504
EMDN description: HEV ANTIBODY IGG
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 01:26

Manufacturer products Authorised representative products Authorised representative actors View details

06970301452522

WANTAI HEV-IgM ELISA

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Manufacturer SRN: CN-MF-000040626
UDI-DI: 06970301452522
Basic UDI-DI: B-06970301452522
Reference: WE-7196
EMDN: W0105020505
EMDN description: HEV ANTIBODY IGM
First on market country: France
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 01:26

Manufacturer products Authorised representative products Authorised representative actors View details

06970301452492

WANTAI HAV-IgM ELISA

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Manufacturer SRN: CN-MF-000040626
UDI-DI: 06970301452492
Basic UDI-DI: B-06970301452492
Reference: WA-1196
EMDN: W0105020104
EMDN description: HAV ANTIBODY IGM
First on market country: Netherlands
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 01:26

Manufacturer products Authorised representative products Authorised representative actors View details

06970301452478

AiDTM HBsAg ELISA

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Manufacturer SRN: CN-MF-000040626
UDI-DI: 06970301452478
Basic UDI-DI: B-06970301452478
Reference: WB-12480
EMDN: W0105020201
EMDN description: HEPATITIS B SURFACE ANTIGEN
First on market country: Hungary
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 01:26

Manufacturer products Authorised representative products Authorised representative actors View details