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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

Last updated

22.09.2026 08:45

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86 device results listed.

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IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548258915
Basic UDI-DI: 868511580PCR44JE
Reference: LYO44WS24
EMDN: W0105020105
EMDN description: HEPATITIS A VIRUS - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 09:05

Manufacturer products View details

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IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685115805492
Basic UDI-DI: 868511580PCR44JE
Reference: LYO44WS48
EMDN: W0105020105
EMDN description: HEPATITIS A VIRUS - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 09:05

Manufacturer products View details

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IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08685115805539
Basic UDI-DI: 868511580PCR44JE
Reference: LYO44WS96
EMDN: W0105020105
EMDN description: HEPATITIS A VIRUS - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 09:05

Manufacturer products View details

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IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595031810
Basic UDI-DI: 868511580PCR44JE
Reference: CFP44P25
EMDN: W0105020105
EMDN description: HEPATITIS A VIRUS - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 09:05

Manufacturer products View details

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IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595033463
Basic UDI-DI: 868511580PCR44JE
Reference: CFP44P50
EMDN: W0105020105
EMDN description: HEPATITIS A VIRUS - NA REAGENTS
First on market country: -
Authorised representative: -
Last updated: 22.09.2026 09:05

Manufacturer products View details

HAV qPCR Kit

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548257710
Basic UDI-DI: 868511580PCR44JE
Reference: CFP44P100
EMDN: W0105020105
EMDN description: HEPATITIS A VIRUS - NA REAGENTS
First on market country: Türkiye
Authorised representative: -
Last updated: 22.09.2026 09:05

Manufacturer products View details

Hepatitis A Virus RNA Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792731967
Basic UDI-DI: B-06955792731967
Reference: S3179E-24
EMDN: W0105020105
EMDN description: HEPATITIS A VIRUS - NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 03.08.2026 21:56

Manufacturer products Authorised representative products Authorised representative actors View details

Rapid HAV IgG/IgM Combo Test Card

1H16C2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: 06921963715272
Basic UDI-DI: B-06921963715272
Reference: 1H16C2
EMDN: W0105020102
EMDN description: HAV ANTIBODY (TOTAL)
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 03.08.2026 05:58

Manufacturer products Authorised representative products Authorised representative actors View details

ZENA MAX Hepatitis A Virus Real Time PCR Detection Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Advanced Molecular Diagnostics Ltd
Manufacturer SRN: UK-MF-000043044
UDI-DI: 05061059980533
Basic UDI-DI: B-05061059980533
Reference: KD764241- 100
EMDN: W0105020105
EMDN description: HEPATITIS A VIRUS - NA REAGENTS
First on market country: Malta
Authorised representative: Advena Limited
Last updated: 02.08.2026 18:46

Manufacturer products Authorised representative products Authorised representative actors View details

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

Antibody to Hepatitis A Virus (CLIA)

105-038862-00, 105-038863-00, 105-045982-00, 105-045981-00, 105-045980-00, 105-045979-00

IVD Class CIVDR 2017/746On the marketDirect markingProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053049207
Basic UDI-DI: 69449040AB74000405G
Reference: 105-038862-00
EMDN: W0105020102
EMDN description: HAV ANTIBODY (TOTAL)
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-HAV Total

VIDAS® Anti-HAV Total

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

Manufacturer: bioMérieux SA
Manufacturer SRN: FR-MF-000004436
UDI-DI: 03573026064792
Basic UDI-DI: 357302BUDI000232SZ
Reference: 30312
EMDN: W0105020102
EMDN description: HAV ANTIBODY (TOTAL)
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 20:48

Manufacturer products View details

VIDAS® HAV IgM

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

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 IgG/IgM Combo Rapid Test Cassette

HAV IgG/IgM Combo Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-IHAGM-4255D
Basic UDI-DI: B-IHAGM-4255D
Reference: IHA-402
EMDN: W0105020102
EMDN description: HAV 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

HAV IgM Rapid Test Cassette

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

LIAISON® Anti-HAV

LIAISON® Anti-HAV

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: DiaSorin Italia S.p.A.
Manufacturer SRN: IT-MF-000029422
UDI-DI: 08056771100151
Basic UDI-DI: 80567713101703Q
Reference: 310170
EMDN: W0105020102
EMDN description: HAV ANTIBODY (TOTAL)
First on market country: Italy
Authorised representative: -
Last updated: 23.07.2026 01:39

Manufacturer products View details

ADVIA Centaur aHAVT assay

IVDR_67_TTN_DUB-C_B_KIT_aHAVT

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414481876
Basic UDI-DI: 0405686900748W2
Reference: 10322676
EMDN: W0105020102
EMDN description: HAV ANTIBODY (TOTAL)
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 17.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

HAV IGG IGM Rapid Test

HAV IGG IGM Rapid Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840312096
Basic UDI-DI: B-69743840312096
Reference: 3023101
EMDN: W0105020102
EMDN description: HAV ANTIBODY (TOTAL)
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:12

Manufacturer products Authorised representative products Authorised representative actors View details

HAV-W21-GM（25PCS）

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Lysun Biotechnology Co., Ltd
Manufacturer SRN: CN-MF-000010254
UDI-DI: D-6971771200989A5
Basic UDI-DI: B-6971771200989A5
Reference: HAV-W21-GM
EMDN: W0105020102
EMDN description: HAV ANTIBODY (TOTAL)
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 17.07.2026 03:57

Manufacturer products Authorised representative products Authorised representative actors View details