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33 device results listed.

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Hepatitis A Virus IgM Antibody (CLIA)

105-038860-00, 105-038861-00

IVD Class CIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053049283
Basic UDI-DI: 69449040AB74000395X
Reference: 105-038860-00
EMDN: W0105020104
EMDN description: HAV 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® HAV IgM

IVD Class BIVDR 2017/746On the marketHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026064747
Basic UDI-DI: 357302BUDI000593U4
Reference: 30307
EMDN: W0105020104
EMDN description: HAV ANTIBODY IGM
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:48

Manufacturer products View details

LIAISON® HAV IgM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771100175
Basic UDI-DI: B-08056771100175
Reference: 310180
EMDN: W0105020104
EMDN description: HAV ANTIBODY IGM
First on market country: Italy
Authorised representative: -
Last updated: 28.07.2026 03:39

Manufacturer products View details

HAV 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-IHA-402MD
Basic UDI-DI: B-IHA-402MD
Reference: IHA-402
EMDN: W0105020104
EMDN description: HAV ANTIBODY IGM
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

Diagnostic kit for anti-HAV IgM( Colloidal Gold)

HAV-IgM strip cassette

IVD generalIVDDNo longer on the marketProfessional testingSingle use

Manufacturer: Nantong EgensBiotechnology Co.,Ltd.
Manufacturer SRN: CN-MF-000021561
UDI-DI: D-693757990612QC
Basic UDI-DI: B-693757990612QC
Reference: HAV-IgM 501201 HAV-IgM 251202
EMDN: W0105020104
EMDN description: HAV ANTIBODY IGM
First on market country: -
Authorised representative: SUNGO Europe B.V.
Last updated: 17.07.2026 03:48

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur® HAV IgM

IVDR_67_TTN_DUB-C_B_KIT_aHAVM

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414479996
Basic UDI-DI: 0405686900747VY
Reference: 10309083
EMDN: W0105020104
EMDN description: HAV ANTIBODY IGM
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:13

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM Hepatitis A IgM (aHAVM)

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414597737
Basic UDI-DI: 0405686900747VY
Reference: 10995444
EMDN: W0105020104
EMDN description: HAV ANTIBODY IGM
First on market country: -
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 15.07.2026 22:49

Manufacturer products Authorised representative products Authorised representative actors View details

INNODX HAV IgM CMIA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Xiamen Innodx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000041071
UDI-DI: D-KR-HAV-02100CWL
Basic UDI-DI: B-KR-HAV-02100CWL
Reference: KR-HAV-02100C
EMDN: W0105020104
EMDN description: HAV 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

D-IM4407010J4

HAV 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-IM4407010J4
Basic UDI-DI: B-IM4407010J4
Reference: IM4407010
EMDN: W0105020104
EMDN description: HAV 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

D-IM4406010HV

HAV 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-IM4406010HV
Basic UDI-DI: B-IM4406010HV
Reference: IM4406010
EMDN: W0105020104
EMDN description: HAV 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

D-IM4405010HN

HAV 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-IM4405010HN
Basic UDI-DI: B-IM4405010HN
Reference: IM4405010
EMDN: W0105020104
EMDN description: HAV ANTIBODY IGM
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:24

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4401010GS

HAV 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-IM4401010GS
Basic UDI-DI: B-IM4401010GS
Reference: IM4401010
EMDN: W0105020104
EMDN description: HAV ANTIBODY IGM
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:15

Manufacturer products Authorised representative products Authorised representative actors View details

HAV 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-IHA-R4029E
Basic UDI-DI: B-IHA-R4029E
Reference: IHA-R402
EMDN: W0105020104
EMDN description: HAV ANTIBODY IGM
First on market country: Austria
Authorised representative: VidaQuick Biotech S.L.
Last updated: 14.07.2026 01:09

Manufacturer products Authorised representative products Authorised representative actors View details

HAV IgM Rapid Test Cassette (Serum/Plasma)

GCHAV(IgM)-302Ba

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GCHAV(IgM)-302BaVF
Basic UDI-DI: B-GCHAV(IgM)-302BaVF
Reference: GCHAV(IgM)-302Ba
EMDN: W0105020104
EMDN description: HAV 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

Anti-HAV IgM Hepatitis A Virus IgM Antibody (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-AHAVIgM706-AE79
Basic UDI-DI: B-AHAVIgM706-AE79
Reference: AHAVIgM706-AE10Y, AHAVIgM706-AE10N, AHAVIgM706-AE20Y, AHAVIgM706-AE20N
EMDN: W0105020104
EMDN description: HAV ANTIBODY IGM
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 12.07.2026 21:34

Manufacturer products Authorised representative products Authorised representative actors View details

Access HAV IgM (Reagent Pack)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: D-34210FQ
Basic UDI-DI: B-34210FQ
Reference: 34210
EMDN: W0105020104
EMDN description: HAV ANTIBODY IGM
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 11.07.2026 18:27

Manufacturer products Authorised representative products Authorised representative actors View details

HAV IgM Rapid Test Device(Serum/Plasma)

A531401D

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Cybereagen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000037850
UDI-DI: 06976753476024
Basic UDI-DI: B-06976753476024
Reference: A531401D
EMDN: W0105020104
EMDN description: HAV ANTIBODY IGM
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 07.07.2026 01:00

Manufacturer products Authorised representative products Authorised representative actors View details

HAV IgM Rapid Test

GIHAVm

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032462
UDI-DI: 06976202762623
Basic UDI-DI: B-06976202762623
Reference: GIHAVm-402
EMDN: W0105020104
EMDN description: HAV 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

HAV lgM Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Beijing Jinwofu Bioengineering Technology Co., Ltd.
Manufacturer SRN: CN-MF-000035739
UDI-DI: 06974854620780
Basic UDI-DI: B-06974854620780
Reference: P2202825
EMDN: W0105020104
EMDN description: HAV ANTIBODY IGM
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 20:53

Manufacturer products Authorised representative products Authorised representative actors View details

06974323018315

Hepatitis A 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: 06974323018315
Basic UDI-DI: B-06974323018315
Reference: IH007
EMDN: W0105020104
EMDN description: HAV 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