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EUDAMED Device Search

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

Last updated

01.08.2026 18:27

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228 device results listed.

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AiDTM HBsAg ELISA

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Manufacturer SRN: CN-MF-000040626
UDI-DI: 06970301452461
Basic UDI-DI: B-06970301452461
Reference: WB-1296
EMDN: W0105020201
EMDN description: HEPATITIS B SURFACE ANTIGEN
First on market country: Hungary
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 01:25

Manufacturer products Authorised representative products Authorised representative actors View details

AiD anti-HCV ELISA Plus

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Manufacturer SRN: CN-MF-000040626
UDI-DI: 06970301452454
Basic UDI-DI: B-06970301452454
Reference: WC-31S480
EMDN: W0105020303
EMDN description: HCV ANTIBODY (TOTAL)
First on market country: Hungary
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 01:25

Manufacturer products Authorised representative products Authorised representative actors View details

AiD anti-HCV ELISA Plus

IVD Annex II List AIVDDOn the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Manufacturer SRN: CN-MF-000040626
UDI-DI: 06970301452447
Basic UDI-DI: B-06970301452447
Reference: WC-31S96
EMDN: W0105020303
EMDN description: HCV ANTIBODY (TOTAL)
First on market country: Hungary
Authorised representative: QbD RepS BV
Last updated: 30.06.2026 01:25

Manufacturer products Authorised representative products Authorised representative actors View details

Hepatitis E Virus IgM Antibody (CLIA)

-

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053049184
Basic UDI-DI: 69449040AB74000415J
Reference: 105-038867-00
EMDN: W0105020505
EMDN description: HEV ANTIBODY IGM
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:11

Manufacturer products Authorised representative products Authorised representative actors View details

Antibody to Hepatitis A Virus (CLIA)

-

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053049245
Basic UDI-DI: 69449040AB74000405G
Reference: 105-038863-00
EMDN: W0105020102
EMDN description: HAV ANTIBODY (TOTAL)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:11

Manufacturer products Authorised representative products Authorised representative actors View details

Hepatitis A Virus IgM Antibody (CLIA)

-

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053049306
Basic UDI-DI: 69449040AB74000395X
Reference: 105-038861-00
EMDN: W0105020104
EMDN description: HAV ANTIBODY IGM
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:11

Manufacturer products Authorised representative products Authorised representative actors View details

Hepatitis E Virus IgG Antibody (CLIA)

-

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053049320
Basic UDI-DI: 69449040AB74000425L
Reference: 105-038864-00
EMDN: W0105020504
EMDN description: HEV ANTIBODY IGG
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:11

Manufacturer products Authorised representative products Authorised representative actors View details

HEV IgG Control

-

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053074834
Basic UDI-DI: 69449040AB74000425L
Reference: 105-045975-00
EMDN: W0105020504
EMDN description: HEPATITIS VIRUS CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:11

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-HAV Control

-

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053074841
Basic UDI-DI: 69449040AB74000405G
Reference: 105-045981-00
EMDN: W0105020102
EMDN description: HEPATITIS VIRUS CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:11

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-HAV Control

-

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053074858
Basic UDI-DI: 69449040AB74000405G
Reference: 105-045979-00
EMDN: W0105020102
EMDN description: HEPATITIS VIRUS CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:11

Manufacturer products Authorised representative products Authorised representative actors View details

HEV IgG Control

-

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053074865
Basic UDI-DI: 69449040AB74000425L
Reference: 105-045976-00
EMDN: W0105020504
EMDN description: HEPATITIS VIRUS CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:11

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-HAV Control

-

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053074872
Basic UDI-DI: 69449040AB74000405G
Reference: 105-045980-00
EMDN: W0105020102
EMDN description: HEPATITIS VIRUS CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:11

Manufacturer products Authorised representative products Authorised representative actors View details

HEV IgG Control

-

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053074889
Basic UDI-DI: 69449040AB74000425L
Reference: 105-045978-00
EMDN: W0105020504
EMDN description: HEPATITIS VIRUS CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:11

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-HAV Control

-

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053074896
Basic UDI-DI: 69449040AB74000405G
Reference: 105-045982-00
EMDN: W0105020102
EMDN description: HEPATITIS VIRUS CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:11

Manufacturer products Authorised representative products Authorised representative actors View details

HEV IgG Control

-

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053074902
Basic UDI-DI: 69449040AB74000425L
Reference: 105-045977-00
EMDN: W0105020504
EMDN description: HEPATITIS VIRUS CONTROLS - INF.IMM.
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 29.06.2026 14:11

Manufacturer products Authorised representative products Authorised representative actors View details

Hepatitis C Virus RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

Hepatitis C Virus RNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

IVD Annex II List AIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792731141
Basic UDI-DI: B-06955792731141
Reference: S3119E-24
EMDN: W0105020307
EMDN description: HEPATITIS C VIRUS - NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

Hepatitis B Virus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

Hepatitis B Virus DNA Quantitative Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

IVD Annex II List AIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792731134
Basic UDI-DI: B-06955792731134
Reference: S3118E-48
EMDN: W0105020216
EMDN description: HEPATITIS B VIRUS - NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

Hepatitis C Virus Genotype Diagnostic Kit (PCR-Fluorescence Probing)

Hepatitis C Virus Genotype Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792731127
Basic UDI-DI: B-06955792731127
Reference: S3034E
EMDN: W0105020307
EMDN description: HEPATITIS C VIRUS - NA REAGENTS
First on market country: Bulgaria
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

Hepatitis B Virus Genotype Diagnostic Kit (PCR-Fluorescence Probing)

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Sansure Biotech Inc.
Manufacturer SRN: CN-MF-000011392
UDI-DI: 06955792731110
Basic UDI-DI: B-06955792731110
Reference: S3035E
EMDN: W0105020218
EMDN description: HEPATITIS B VIRUS - GENOTYPING - NA REAGENTS
First on market country: France
Authorised representative: Obelis s.a.
Last updated: 28.06.2026 20:30

Manufacturer products Authorised representative products Authorised representative actors View details

HAV IgM Rapid Test

A40310125, A40310140, A40310225, A40310240

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804831998
Basic UDI-DI: 69528048A403100XP
Reference: A40310
EMDN: W0105020104
EMDN description: HAV ANTIBODY IGM
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 12:33

Manufacturer products Authorised representative products Authorised representative actors View details