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71 device results listed.

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HEPATITIS E VIRCLIA® IgG AVIDITY MONOTEST

VCM093

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

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040327838
Basic UDI-DI: 843604032VCM09301DK
Reference: VCM093
EMDN: W0105020504
EMDN description: HEV ANTIBODY IGG
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:49

Manufacturer products View details

HEPATITIS E VIRCLIA® IgM MONOTEST

VCM067

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

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040326954
Basic UDI-DI: 843604032VCM06701DJ
Reference: VCM067
EMDN: W0105020505
EMDN description: HEV ANTIBODY IGM
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:48

Manufacturer products View details

HEPATITIS E VIRCLIA® IgG MONOTEST

VCM066

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

Manufacturer: Vircell, S.L
Manufacturer SRN: ES-MF-000004099
UDI-DI: 08436040326947
Basic UDI-DI: 843604032VCM06601DD
Reference: VCM066
EMDN: W0105020504
EMDN description: HEV ANTIBODY IGG
First on market country: Spain
Authorised representative: -
Last updated: 31.07.2026 22:48

Manufacturer products View details

Hepatitis E Virus IgG Antibody (CLIA)

105-038864-00, 105-038865-00, 105-045978-00, 105-045977-00, 105-045975-00, 105-045976-00

IVD Class CIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053049313
Basic UDI-DI: 69449040AB74000425L
Reference: 105-038865-00
EMDN: W0105020504
EMDN description: HEV ANTIBODY IGG
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

Hepatitis E Virus IgM Antibody (CLIA)

105-038866-00, 105-038867-00

IVD Class CIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053049122
Basic UDI-DI: 69449040AB74000415J
Reference: 105-038866-00
EMDN: W0105020505
EMDN description: HEV ANTIBODY IGM
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:50

Manufacturer products Authorised representative products Authorised representative actors View details

VIDAS® Anti-HEV IgG

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026467326
Basic UDI-DI: 357302BUDI000856UD
Reference: 418116
EMDN: W0105020504
EMDN description: HEV ANTIBODY IGG
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:57

Manufacturer products View details

VIDAS® Anti-HEV IgM

IVD Class CIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026467319
Basic UDI-DI: 357302BUDI000855UB
Reference: 418115
EMDN: W0105020505
EMDN description: HEV ANTIBODY IGM
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:57

Manufacturer products View details

HEV RNA QUANTITATION (QT)

HEVONEQT.CE

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DIA.PRO DIAGNOSTIC BIOPROBES S.R.L.
Manufacturer SRN: IT-MF-000029123
UDI-DI: 08050616042644
Basic UDI-DI: B-08050616042644
Reference: HEVONEQT.CE
EMDN: W0105020507
EMDN description: HEPATITIS E VIRUS - NA REAGENTS
First on market country: Italy
Authorised representative: -
Last updated: 25.07.2026 00:52

Manufacturer products View details

HEV IgG/IgM Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IHE-302NL
Basic UDI-DI: B-IHE-302NL
Reference: IHE-302
EMDN: W0105020503
EMDN description: HEV ANTIBODY (TOTAL)
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.07.2026 06:47

Manufacturer products Authorised representative products Authorised representative actors View details

LIAISON® MUREX Anti-HEV IgM

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771103916
Basic UDI-DI: 805677131128047
Reference: 311280
EMDN: W0105020505
EMDN description: HEV ANTIBODY IGM
First on market country: Italy
Authorised representative: -
Last updated: 23.07.2026 01:39

Manufacturer products View details

LIAISON® MUREX Anti-HEV IgG

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771103879
Basic UDI-DI: 805677131127044
Reference: 311270
EMDN: W0105020504
EMDN description: HEV ANTIBODY IGG
First on market country: Italy
Authorised representative: -
Last updated: 23.07.2026 01:39

Manufacturer products View details

+ENTIHEVM078009

NovaLisa® Hepatitis E Virus (HEV) IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIHEVM078009
Basic UDI-DI: B-+ENTIHEVM078009
Reference: HEVM0780
EMDN: W0105020505
EMDN description: HEV ANTIBODY IGM
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:14

Manufacturer products View details

+ENTIHEVG078003

NovaLisa® Hepatitis E Virus (HEV) IgG

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingSingle use

Manufacturer: Gold Standard Diagnostics Frankfurt GmbH
Manufacturer SRN: DE-MF-000025020
UDI-DI: +ENTIHEVG078003
Basic UDI-DI: B-+ENTIHEVG078003
Reference: HEVG0780
EMDN: W0105020504
EMDN description: HEV ANTIBODY IGG
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 13:14

Manufacturer products View details

INNODX HEV IgM CMIA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-HEV-02100CZG
Basic UDI-DI: B-KR-HEV-02100CZG
Reference: KR-HEV-02100C
EMDN: W0105020505
EMDN description: HEV ANTIBODY IGM
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:43

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX HEV IgG CMIA

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-HEV-01100CZ5
Basic UDI-DI: B-KR-HEV-01100CZ5
Reference: KR-HEV-01100C
EMDN: W0105020504
EMDN description: HEV ANTIBODY IGG
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 14.07.2026 03:43

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4492043LK

HEV IgM Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4492043LK
Basic UDI-DI: B-IM4492043LK
Reference: IM4492043
EMDN: W0105020505
EMDN description: HEV ANTIBODY IGM
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:36

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4492017LJ

HEV IgG Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4492017LJ
Basic UDI-DI: B-IM4492017LJ
Reference: IM4492017
EMDN: W0105020504
EMDN description: HEV ANTIBODY IGG
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:36

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4491043LC

HEV IgM Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4491043LC
Basic UDI-DI: B-IM4491043LC
Reference: IM4491043
EMDN: W0105020505
EMDN description: HEV ANTIBODY IGM
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:35

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4491017LB

HEV IgG Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4491017LB
Basic UDI-DI: B-IM4491017LB
Reference: IM4491017
EMDN: W0105020504
EMDN description: HEV ANTIBODY IGG
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:35

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4407043JK

HEV IgM Antibody Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4407043JK
Basic UDI-DI: B-IM4407043JK
Reference: IM4407043
EMDN: W0105020505
EMDN description: HEV ANTIBODY IGM
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:27

Manufacturer products Authorised representative products Authorised representative actors View details