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93 device results listed.

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Hepatitis A Virus Rapid Test (Whole Blood/Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: SAFECARE BIOTECH (HANGZHOU) CO., LTD.
Manufacturer SRN: CN-MF-000019109
UDI-DI: D-697424646HAV000GQVC
Basic UDI-DI: B-697424646HAV000GQVC
Reference: HAV-4012/HAV-4022/HAV-3012/HAV-3022
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Germany
Authorised representative: Wellkang Ltd
Last updated: 17.07.2026 04:06

Manufacturer products Authorised representative products Authorised representative actors View details

HAV IgM Rapid Test Cassette (Serum/Plasma)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testing

Manufacturer: Kalians Corporation
Manufacturer SRN: EG-MF-000050142
UDI-DI: 62230182723972
Basic UDI-DI: B-62230182723972
Reference: D-788 001
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:38

Manufacturer products Authorised representative products Authorised representative actors View details

HAV IgM Rapid Test Cassette (Serum/Plasma)

1192 001

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Egyptian Company For Biotechnology-Spectrum Diagnostics
Manufacturer SRN: EG-MF-000032599
UDI-DI: 62230041043500
Basic UDI-DI: B-62230041043500
Reference: 1192 001
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 17.07.2026 03:30

Manufacturer products Authorised representative products Authorised representative actors View details

HEV IgG/IgM Rapid Test (Serum/Plasma)

IHE-6013

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Anhui Formaster Biosci Co., Ltd.
Manufacturer SRN: CN-MF-000002305
UDI-DI: 06974785750600
Basic UDI-DI: B-06974785750600
Reference: IHE-6013
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 16.07.2026 19:12

Manufacturer products Authorised representative products Authorised representative actors View details

NADAL® HAV IgG/IgM Test

HAV IgG/IgM Test

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagentSingle use

Manufacturer: nal von minden GmbH
Manufacturer SRN: DE-MF-000013321
UDI-DI: D-nvm-622970N-304Z
Basic UDI-DI: B-nvm-622970N-304Z
Reference: 622970N-30
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:29

Manufacturer products View details

HEV IgG/IgM Rapid Test

VIHEVb-422

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VIHEVb-422YB
Basic UDI-DI: B-VIHEVb-422YB
Reference: VIHEVb-422
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:23

Manufacturer products Authorised representative products Authorised representative actors View details

HEV IgM Rapid Test

VIHE-402

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VIHE-402LJ
Basic UDI-DI: B-VIHE-402LJ
Reference: VIHE-402
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:23

Manufacturer products Authorised representative products Authorised representative actors View details

RightSign

IHCV-C31

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: HangZhou Biotest Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000008191
UDI-DI: D-IHCV-C31JH
Basic UDI-DI: B-IHCV-C31JH
Reference: IHCV-C31
EMDN: W0105090202
EMDN description: HCV ANTIBODY -RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:09

Manufacturer products Authorised representative products Authorised representative actors View details

RightSign

IHBSG-C31

IVD Annex II List AIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: HangZhou Biotest Biotech Co.,Ltd.
Manufacturer SRN: CN-MF-000008191
UDI-DI: D-IHBSG-C31AR
Basic UDI-DI: B-IHBSG-C31AR
Reference: IHBSG-C31
EMDN: W0105090201
EMDN description: HBSAG - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:09

Manufacturer products Authorised representative products Authorised representative actors View details

Hepatitis A Virus Antibody Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-HAV-D02aCP
Basic UDI-DI: B-HAV-D02aCP
Reference: HAV-D02a
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 00:52

Manufacturer products Authorised representative products Authorised representative actors View details

Accu-Tell® HAV IgM/IgG Strip(Serum/Plasma)

Strip

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: D-ABT-IDT-A226UY
Basic UDI-DI: B-ABT-IDT-A226UY
Reference: ABT-IDT-B226
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 12.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

Accu-Tell® HAV IgM Strip (Serum/Plasma)

Strip

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: AccuBioTech Co., Ltd.
Manufacturer SRN: CN-MF-000025172
UDI-DI: D-ABT-IDT-A218UZ
Basic UDI-DI: B-ABT-IDT-A218UZ
Reference: ABT-IDT-A218
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 12.07.2026 21:26

Manufacturer products Authorised representative products Authorised representative actors View details

Hepatitis E Test Device(Serum/plasma/whole blood)

HEPE241

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Neo-nostics (Suzhou) Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000013087
UDI-DI: 86979834610375
Basic UDI-DI: B-86979834610375
Reference: HEPE241
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 12.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

Hepatitis A Test Device(Serum/plasma/whole blood)

HEPA240

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Neo-nostics (Suzhou) Bioengineering Co., Ltd.
Manufacturer SRN: CN-MF-000013087
UDI-DI: 86979834610351
Basic UDI-DI: B-86979834610351
Reference: HEPA240
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 12.07.2026 17:22

Manufacturer products Authorised representative products Authorised representative actors View details

HEV IgM Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698601283
Basic UDI-DI: B-16972698601283
Reference: P231113
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 09:52

Manufacturer products Authorised representative products Authorised representative actors View details

HAV IgM Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.
Manufacturer SRN: CN-MF-000013495
UDI-DI: 16972698600156
Basic UDI-DI: B-16972698600156
Reference: P231103
EMDN: W0105090299
EMDN description: HEPATITIS VIRUSES - RT & POC - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 11.07.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

OraQuick HCV Rapid Antibody Test

1001-0274

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

Manufacturer: OraSure Technologies, Inc.
Manufacturer SRN: US-MF-000009941
UDI-DI: 10608337000563
Basic UDI-DI: B-10608337000563
Reference: 1001-0274
EMDN: W0105090202
EMDN description: HCV ANTIBODY -RT & POC
First on market country: Austria
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 02:20

Manufacturer products Authorised representative products Authorised representative actors View details

08693285187966

HBsAg Test Pro

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: 08693285187966
Basic UDI-DI: B-08693285187966
Reference: TIHB04340
EMDN: W0105090201
EMDN description: HBSAG - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:34

Manufacturer products View details

08693285187959

Anti-HCV Test Pro

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: 08693285187959
Basic UDI-DI: B-08693285187959
Reference: TIHC02340
EMDN: W0105090202
EMDN description: HCV ANTIBODY -RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:34

Manufacturer products View details

08693285187904

HBsAg Test Single

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: 08693285187904
Basic UDI-DI: B-08693285187904
Reference: TIHB04205
EMDN: W0105090201
EMDN description: HBSAG - RT & POC
First on market country: Türkiye
Authorised representative: -
Last updated: 09.07.2026 06:34

Manufacturer products View details