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28 device results listed.

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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 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 IgM

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

LIAISON® MUREX Anti-HEV IgM

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

+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

INNODX HEV IgM CMIA

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

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

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

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

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-IM4406043JC
Basic UDI-DI: B-IM4406043JC
Reference: IM4406043
EMDN: W0105020505
EMDN description: HEV ANTIBODY IGM
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:25

Manufacturer products Authorised representative products Authorised representative actors View details

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-IM4403043HP
Basic UDI-DI: B-IM4403043HP
Reference: IM4403043
EMDN: W0105020505
EMDN description: HEV ANTIBODY IGM
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:19

Manufacturer products Authorised representative products Authorised representative actors View details

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-IM4402043HG
Basic UDI-DI: B-IM4402043HG
Reference: IM4402043
EMDN: W0105020505
EMDN description: HEV ANTIBODY IGM
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:17

Manufacturer products Authorised representative products Authorised representative actors View details

HEV IgM Rapid Test Cassette (Serum/Plasma)

GCHEV-302a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCHEV-302aZE
Basic UDI-DI: B-GCHEV-302aZE
Reference: GCHEV-302a
EMDN: W0105020505
EMDN description: HEV ANTIBODY IGM
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

HEV IgM Rapid Test Cassette (Serum/Plasma)

GCHEV-302a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GCHEV-302aHGYW
Basic UDI-DI: B-GCHEV-302aHGYW
Reference: GCHEV-302a
EMDN: W0105020505
EMDN description: HEV ANTIBODY IGM
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

RapidFor™ HEV IgM Rapid Test Kit

VMD105

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548255655
Basic UDI-DI: B-08683548255655
Reference: VMD105
EMDN: W0105020505
EMDN description: HEV ANTIBODY IGM
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:14

Manufacturer products View details

EVM.CE

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIA.PRO DIAGNOSTIC BIOPROBES S.R.L.
Manufacturer SRN: IT-MF-000029123
UDI-DI: 08050616040183
Basic UDI-DI: B-08050616040183
Reference: EVM.CE
EMDN: W0105020505
EMDN description: HEV ANTIBODY IGM
First on market country: Italy
Authorised representative: -
Last updated: 07.07.2026 19:10

Manufacturer products View details

HEV IgG/IgM Rapid Test

GIHEV

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032462
UDI-DI: 06976202763309
Basic UDI-DI: B-06976202763309
Reference: GIHEV-422
EMDN: W0105020505
EMDN description: HEV ANTIBODY IGM
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 07.07.2026 00:39

Manufacturer products Authorised representative products Authorised representative actors View details

HEV IgM Rapid Test

GIHEVm

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032462
UDI-DI: 06976202762500
Basic UDI-DI: B-06976202762500
Reference: GIHEVm-402
EMDN: W0105020505
EMDN description: HEV ANTIBODY IGM
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 07.07.2026 00:37

Manufacturer products Authorised representative products Authorised representative actors View details

Hepatitis E Virus IgM Antibody Rapid Test Cassette (Colloidal Gold Method)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323018346
Basic UDI-DI: B-06974323018346
Reference: IH008
EMDN: W0105020505
EMDN description: HEV ANTIBODY IGM
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 19:01

Manufacturer products Authorised representative products Authorised representative actors View details

Hepatitis E Virus IgM Antibody Rapid Test Cassette (Colloidal Gold Method)

IVD generalIVDDOn the marketProfessional testingReagentSingle use

Manufacturer: Beijing Applied Biological Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000012338
UDI-DI: 06974323018339
Basic UDI-DI: B-06974323018339
Reference: IH008
EMDN: W0105020505
EMDN description: HEV ANTIBODY IGM
First on market country: Germany
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 06.07.2026 19:01

Manufacturer products Authorised representative products Authorised representative actors View details