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EUDAMED Device Search

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

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09.07.2026 02:37

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Active filter:Manufacturer SRN:CN-MF-000001118

72 device results listed.

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Prostate Specific Antigen (PSA) Rapid Test

Prostate Specific Antigen (PSA) Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238910469
Basic UDI-DI: B-06974238910469
Reference: HPSA038
EMDN: W0102030122
EMDN description: EARLY PROSTATE CANCER ANTIGEN - 2
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:58

Manufacturer products Authorised representative products Authorised representative actors View details

Fecal Occult Blood (FOB) Rapid Test

Fecal Occult Blood (FOB) Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238910452
Basic UDI-DI: B-06974238910452
Reference: HFOB037
EMDN: W0102039013
EMDN description: FECAL OCCULT BLOOD (IC)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:58

Manufacturer products Authorised representative products Authorised representative actors View details

Carcinoembryonic antigen (CEA) Rapid Test

Carcinoembryonic antigen (CEA) Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238910445
Basic UDI-DI: B-06974238910445
Reference: HCEA036
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:58

Manufacturer products Authorised representative products Authorised representative actors View details

Alpha-Fetoprotein (AFP) Rapid Test

Alpha-Fetoprotein (AFP) Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238910438
Basic UDI-DI: B-06974238910438
Reference: HAFP035
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:58

Manufacturer products Authorised representative products Authorised representative actors View details

H. pylori Antigen Rapid Test

H. pylori Antigen Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238910407
Basic UDI-DI: B-06974238910407
Reference: HHP033G
EMDN: W0105010401
EMDN description: H. PYLORI ANTIGEN DETECTION
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:58

Manufacturer products Authorised representative products Authorised representative actors View details

Campylobacter Antigen Rapid Test

Campylobacter Antigen Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238910391
Basic UDI-DI: B-06974238910391
Reference: HCP032G
EMDN: W0105011401
EMDN description: CAMPYLOBACTER DIRECT ANTIGEN DETECTION
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:58

Manufacturer products Authorised representative products Authorised representative actors View details

Rotavirus Antigen Rapid Test

Rotavirus Antigen Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238910377
Basic UDI-DI: B-06974238910377
Reference: HROTA027G
EMDN: W0105040606
EMDN description: ROTAVIRUS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:58

Manufacturer products Authorised representative products Authorised representative actors View details

Gonorrhea Antigen Rapid Test

Gonorrhea Antigen Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238910353
Basic UDI-DI: B-06974238910353
Reference: HNG025G
EMDN: W0105010201
EMDN description: GONOCOCCAL ANTIGEN DETECTION
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:58

Manufacturer products Authorised representative products Authorised representative actors View details

Adenovirus Antigen Rapid Test

Adenovirus Antigen Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238910360
Basic UDI-DI: B-06974238910360
Reference: HADV026G
EMDN: W0105040601
EMDN description: ADENOVIRUS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:58

Manufacturer products Authorised representative products Authorised representative actors View details

Sars-CoV-2 Anti-N Binding Antibody Rapid Test

Sars-CoV-2 Anti-N Binding Antibody Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238910346
Basic UDI-DI: B-06974238910346
Reference: HCOV020TN
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:58

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria P.f./Pan Antigen Rapid Test

Malaria P.f./Pan Antigen Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238910322
Basic UDI-DI: B-06974238910322
Reference: HMAL013G
EMDN: W0105050209
EMDN description: PLASMODIUM (MALARIA)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:58

Manufacturer products Authorised representative products Authorised representative actors View details

Chagas IgG/IgM Rapid Test

Chagas IgG/IgM Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238910315
Basic UDI-DI: B-06974238910315
Reference: HCHA011T
EMDN: W0105050202
EMDN description: CHAGAS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:58

Manufacturer products Authorised representative products Authorised representative actors View details

Sars-CoV-2 Anti-RBD Binding Antibody Rapid Test

Sars-CoV-2 Anti-RBD Binding Antibody Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238910308
Basic UDI-DI: B-06974238910308
Reference: HCOV019TRBD
EMDN: W0105040619
EMDN description: CORONAVIRUS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:58

Manufacturer products Authorised representative products Authorised representative actors View details

Leptospira IgG/IgM Rapid Test

Leptospira IgG/IgM Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238910292
Basic UDI-DI: B-06974238910292
Reference: HLEP002T
EMDN: W0105011604
EMDN description: LEPTOSPIRA - NA REAGENTS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:58

Manufacturer products Authorised representative products Authorised representative actors View details

Pregnancy (hCG) Rapid Test

Pregnancy (hCG) Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238910285
Basic UDI-DI: B-06974238910285
Reference: HHCG001
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:58

Manufacturer products Authorised representative products Authorised representative actors View details

Borrelia Burgdorferi Antibody Rapid Test

Borrelia Burgdorferi Antibody Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238910261
Basic UDI-DI: B-06974238910261
Reference: HLYM004T
EMDN: W0105010602
EMDN description: LYME ANTIBODY TOTAL
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:58

Manufacturer products Authorised representative products Authorised representative actors View details

Zika Virus IgG/IgM And NS1 Combo Test

Zika Virus IgG/IgM And NS1 Combo Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238910247
Basic UDI-DI: B-06974238910247
Reference: HZIK010GT
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:58

Manufacturer products Authorised representative products Authorised representative actors View details

Zika virus NS1 Antigen Rapid Test

Zika virus NS1 Antigen Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238910230
Basic UDI-DI: B-06974238910230
Reference: HDEN006G
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:58

Manufacturer products Authorised representative products Authorised representative actors View details

Zika virus IgG/IgM Rapid Test

Zika virus IgG/IgM Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238910223
Basic UDI-DI: B-06974238910223
Reference: :HZIK009T
EMDN: W0105040630
EMDN description: ZIKA VIRUS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:58

Manufacturer products Authorised representative products Authorised representative actors View details

Cryptosporidium Parvum Antigen Rapid Test

Cryptosporidium Parvum Antigen Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Immuno Biotech Co., Ltd
Manufacturer SRN: CN-MF-000001118
UDI-DI: 06974238910216
Basic UDI-DI: B-06974238910216
Reference: HCRY031G
EMDN: W0104050203
EMDN description: CRYPTOSPORIDIUM
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 17:58

Manufacturer products Authorised representative products Authorised representative actors View details