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276 device results listed.

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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)

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

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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

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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

06955792731110

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

06950617420255

IM4402017 IM4403017 IM4406017 IM4407017 EIM4492017

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

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617420255
Basic UDI-DI: 69506174IM440017D5
Reference: EIM4492017
EMDN: W0105020504
EMDN description: HEV ANTIBODY IGG
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:46

Manufacturer products Authorised representative products Authorised representative actors View details

06950617416333

IM4405010 IM4401010 IM4406010 IM4407010

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

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617416333
Basic UDI-DI: 69506174IM440010CP
Reference: IM4401010
EMDN: W0105020104
EMDN description: HAV ANTIBODY IGM
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:45

Manufacturer products Authorised representative products Authorised representative actors View details

06950617416326

IM4405010 IM4401010 IM4406010 IM4407010

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

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617416326
Basic UDI-DI: 69506174IM440010CP
Reference: IM4407010
EMDN: W0105020104
EMDN description: HAV ANTIBODY IGM
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:45

Manufacturer products Authorised representative products Authorised representative actors View details

06950617416265

IM4405010 IM4401010 IM4406010 IM4407010

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

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617416265
Basic UDI-DI: 69506174IM440010CP
Reference: IM4406010
EMDN: W0105020104
EMDN description: HAV ANTIBODY IGM
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:45

Manufacturer products Authorised representative products Authorised representative actors View details

06950617415855

IM4402017 IM4403017 IM4406017 IM4407017 EIM4492017

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

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617415855
Basic UDI-DI: 69506174IM440017D5
Reference: IM4402017
EMDN: W0105020504
EMDN description: HEV ANTIBODY IGG
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:45

Manufacturer products Authorised representative products Authorised representative actors View details

06950617415824

IM4402017 IM4403017 IM4406017 IM4407017 EIM4492017

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

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617415824
Basic UDI-DI: 69506174IM440017D5
Reference: IM4403017
EMDN: W0105020504
EMDN description: HEV ANTIBODY IGG
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:45

Manufacturer products Authorised representative products Authorised representative actors View details

06950617415800

IM4402017 IM4403017 IM4406017 IM4407017 EIM4492017

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

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617415800
Basic UDI-DI: 69506174IM440017D5
Reference: IM4406017
EMDN: W0105020504
EMDN description: HEV ANTIBODY IGG
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:45

Manufacturer products Authorised representative products Authorised representative actors View details

06950617410850

IM4405010 IM4401010 IM4406010 IM4407010

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

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617410850
Basic UDI-DI: 69506174IM440010CP
Reference: IM4405010
EMDN: W0105020104
EMDN description: HAV ANTIBODY IGM
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:45

Manufacturer products Authorised representative products Authorised representative actors View details

06950617410843

IM4402017 IM4403017 IM4406017 IM4407017 EIM4492017

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

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: 06950617410843
Basic UDI-DI: 69506174IM440017D5
Reference: IM4407017
EMDN: W0105020504
EMDN description: HEV ANTIBODY IGG
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 08:45

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI HAV IgM (CLIA)

HAV IgM (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145505516
Basic UDI-DI: B-06947145505516
Reference: 130210008M
EMDN: W0105020104
EMDN description: HAV ANTIBODY IGM
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:18

Manufacturer products Authorised representative products Authorised representative actors View details

MAGLUMI Anti-HAV (CLIA)

Anti-HAV (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145505493
Basic UDI-DI: B-06947145505493
Reference: 130210007M
EMDN: W0105020102
EMDN description: HAV ANTIBODY (TOTAL)
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 28.06.2026 01:17

Manufacturer products Authorised representative products Authorised representative actors View details

HCV Rapid Test

IVD Annex II List ANot specifiedOn the marketSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983106009
Basic UDI-DI: B-06936983106009
Reference: IHC-402
EMDN: W0105020303
EMDN description: HCV ANTIBODY (TOTAL)
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 24.06.2026 20:55

Manufacturer products Authorised representative products Authorised representative actors View details