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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

H. pylori Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-IHP-ACO9042T
Basic UDI-DI: B-IHP-ACO9042T
Reference: IHP-ACO904
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Hungary
Authorised representative: VidaQuick Biotech S.L.
Last updated: 07.08.2026 02:19

Manufacturer products Authorised representative products Authorised representative actors View details

H. pylori Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-IHP-ACO9022P
Basic UDI-DI: B-IHP-ACO9022P
Reference: IHP-ACO902
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Denmark
Authorised representative: VidaQuick Biotech S.L.
Last updated: 07.08.2026 02:19

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H. pylori Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-IHP-ACO9012M
Basic UDI-DI: B-IHP-ACO9012M
Reference: IHP-ACO901
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Finland
Authorised representative: VidaQuick Biotech S.L.
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

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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

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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

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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

Dengue NS1 Antigen Rapid Tests

IDAG4001, IDAG4002

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-IDAG400R4
Basic UDI-DI: B-IDAG400R4
Reference: IDAG4001, IDAG4002
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

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

ICFq325, ICFq328

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-ICFq32GX
Basic UDI-DI: B-ICFq32GX
Reference: ICFq325, ICFq328
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 02:18

Manufacturer products Authorised representative products Authorised representative actors View details

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

ICFq312, ICFq318

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-ICFq31GV
Basic UDI-DI: B-ICFq31GV
Reference: ICFq312, ICFq318
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 02:18

Manufacturer products Authorised representative products Authorised representative actors View details

Bordetella pertussis Antigen Rapid Test

B-IBP-ACO502VN

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-IBP-ACO502VN
Basic UDI-DI: B-IBP-ACO502VN
Reference: IBP-ACO502
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Lithuania
Authorised representative: VidaQuick Biotech S.L.
Last updated: 07.08.2026 02:18

Manufacturer products Authorised representative products Authorised representative actors View details

Adenovirus Antigen Rapid Test (Swab)

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-IADq00FE
Basic UDI-DI: B-IADq00FE
Reference: IADq001, IADq002, IADq008
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 02:17

Manufacturer products Authorised representative products Authorised representative actors View details

Adenovirus Antigen Rapid Test (Feces)

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-IAD60075
Basic UDI-DI: B-IAD60075
Reference: IAD6001, IAD6002
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 02:17

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 (SARS-CoV-2) Antigen TestKit(Colloidal Gold)

Cassette

IVD Class CIVDR 2017/746On the marketKitSelf testingSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062712954
Basic UDI-DI: 69520627J012L3
Reference: SL030101NST-2
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Safety summary (SSCP/SSP): SL-CE14-COVAg-6.6 · Rev. A/4
Authorised representative: Mega Eurostar Sp. z o.o.
Last updated: 06.08.2026 08:22

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

Vibrio Cholerae O1/O139 Antigen Rapid Test Cassette (Feces)

IVC6212

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-IVC621ED
Basic UDI-DI: B-IVC621ED
Reference: IVC6212
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: HUMISS TRADING S. L.
Last updated: 06.08.2026 08:11

Manufacturer products Authorised representative products Authorised representative actors View details