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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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20.09.2026 12:32

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Active filter:Manufacturer SRN:CN-MF-000030069

122 device results listed.

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AFP Rapid Tests

TAFP4001, TAFP4002

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-TAFP400ZE
Basic UDI-DI: B-TAFP400ZE
Reference: TAFP4001, TAFP4002
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 02:19

Manufacturer products Authorised representative products Authorised representative actors View details

Mycoplasma pneumoniae Antigen Rapid Test

IMPGp002 IMPGp008

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-MPGp00NP
Basic UDI-DI: B-MPGp00NP
Reference: IMPGp002 IMPGp008
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: HUMISS TRADING S. L.
Last updated: 07.08.2026 02:19

Manufacturer products Authorised representative products Authorised representative actors View details

Syphilis Rapid Tests

ITP4001, ITP4002

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-ITP400FY
Basic UDI-DI: B-ITP400FY
Reference: ITP4001, ITP4002
EMDN: W0105090105
EMDN description: SYPHILIS - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 02:19

Manufacturer products Authorised representative products Authorised representative actors View details

Typhoid IgG/IgM Rapid Test Cassette (WB/S/P)

ISTB4212

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-ISTB4214Y
Basic UDI-DI: B-ISTB4214Y
Reference: ISTB4212
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 02:19

Manufacturer products Authorised representative products Authorised representative actors View details

Streptococcus pneumoniae Antigen Rapid Test

ISP1002

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-ISP100F6
Basic UDI-DI: B-ISP100F6
Reference: ISP1002
EMDN: W0105090109
EMDN description: STREP. PNEUMONIAE - RT & POC
First on market country: Germany
Authorised representative: HUMISS TRADING S. L.
Last updated: 07.08.2026 02:19

Manufacturer products Authorised representative products Authorised representative actors View details

RSV Antigen Rapid Test Cassette (Swab)

IRSVn002, IRSVn008

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-IRSVn00GG
Basic UDI-DI: B-IRSVn00GG
Reference: IRSVn002, IRSVn008
EMDN: W0105099002
EMDN description: RSV - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 02:19

Manufacturer products Authorised representative products Authorised representative actors View details

Rotavirus Antigen Rapid Test

IROT6001, IROT6002

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-IROT6006U
Basic UDI-DI: B-IROT6006U
Reference: IROT6001, IROT6002
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 02:19

Manufacturer products Authorised representative products Authorised representative actors View details

Rotavirus/Adenovirus Antigen Triline Rapid Test

IRA6212, IRA6218

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-IRA621CK
Basic UDI-DI: B-IRA621CK
Reference: IRA6212, IRA6218
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 02:19

Manufacturer products Authorised representative products Authorised representative actors View details

Rotavirus/Adenovirus Antigen Combo Rapid Test Cassette (Feces)

IRA6205

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-IRA620CH
Basic UDI-DI: B-IRA620CH
Reference: IRA6205
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 02:19

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria P.f Antigen Rapid Test Cassette (WB)

IPFGi002

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-IPFGi0075
Basic UDI-DI: B-IPFGi0075
Reference: IPFGi002
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 02:19

Manufacturer products Authorised representative products Authorised representative actors View details

Legionella pneumophila Antigen Rapid Test

ILP1002

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-ILP100CR
Basic UDI-DI: B-ILP100CR
Reference: ILP1002
EMDN: W0105090108
EMDN description: LEGIONELLA - RT & POC
First on market country: Germany
Authorised representative: HUMISS TRADING S. L.
Last updated: 07.08.2026 02:19

Manufacturer products Authorised representative products Authorised representative actors View details

Rotavirus/Adenovirus/Norovirus Antigen Combo Rapid Test Cassette (Feces)

IID6425

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-IID642AD
Basic UDI-DI: B-IID642AD
Reference: IID6425
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: HUMISS TRADING S. L.
Last updated: 07.08.2026 02:19

Manufacturer products Authorised representative products Authorised representative actors View details

H.pylori Antibody Rapid Tests

IHPB4001, IHPB4002

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-IHPB400WS
Basic UDI-DI: B-IHPB400WS
Reference: IHPB4001, IHPB4002
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 02:19

Manufacturer products Authorised representative products Authorised representative actors View details

HMPV Antigen Rapid Test

IHMPn002 IHMPn008

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-IHMPn0092
Basic UDI-DI: B-IHMPn0092
Reference: IHMPn002 IHMPn008
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: HUMISS TRADING S. L.
Last updated: 07.08.2026 02:19

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test

IGMq525

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-IGMq52L2
Basic UDI-DI: B-IGMq52L2
Reference: IGMq525
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: HUMISS TRADING S. L.
Last updated: 07.08.2026 02:19

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria P.f/P.v Antigen Rapid Test Cassette (WB)

IFVGi21

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-IFVGi218T
Basic UDI-DI: B-IFVGi218T
Reference: IFVGi212
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 02:19

Manufacturer products Authorised representative products Authorised representative actors View details

Malaria P.f/Pan Antigen Rapid Test Cassette (WB)

IFPGi212, IFPGi218

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-IFPGi216R
Basic UDI-DI: B-IFPGi216R
Reference: IFPGi212, IFPGi218
EMDN: W0105090401
EMDN description: PLASMODIUM (MALARIA) - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 02:19

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A+B Rapid Test

IFLUn212, IFLUn218

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-IFLUn2198
Basic UDI-DI: B-IFLUn2198
Reference: IFLUn212, IFLUn218
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 02:19

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A+B Rapid Test

IFLUn205, IFLUn208

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-IFLUn2096
Basic UDI-DI: B-IFLUn2096
Reference: IFLUn205, IFLUn208
EMDN: W0105099004
EMDN description: INFLUENZA A AND /OR B - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 02:19

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue IgG/IgM-NS1 Combo Rapid Test Cassette (WB/S/P)

IDEN4325

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-IDEN432UE
Basic UDI-DI: B-IDEN432UE
Reference: IDEN4325
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 07.08.2026 02:18

Manufacturer products Authorised representative products Authorised representative actors View details