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Influenza A/B + H5N1 Antigen Combo Rapid Test

IVD generalIVDDOn the marketKitSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-IFH5-ACO525L5
Basic UDI-DI: B-IFH5-ACO525L5
Reference: IFH5-ACO525
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

Chikungunya Antigen Rapid Test

IVD generalIVDDOn the marketKitSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ICHIG-ACO4025D
Basic UDI-DI: B-ICHIG-ACO4025D
Reference: ICHIG-ACO402
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

Chikungunya IgG/IgM Combo Rapid Test

IVD generalIVDDOn the marketKitSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ICHI-425(SL)EC
Basic UDI-DI: B-ICHI-425(SL)EC
Reference: ICHI-425(SL)
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

D-INCP-ACOR802HZ

COVID-19 Antigen Rapid Test

IVD generalIVDDOn the marketKitSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-INCP-ACOR802HZ
Basic UDI-DI: B-INCP-ACOR802HZ
Reference: INCP-ACOR802
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 11.08.2026 23:31

Manufacturer products Authorised representative products Authorised representative actors View details

Influenza A/B+H1N1 Combo Rapid Test Cassette

IVD generalIVDDOn the marketKitSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-IINA-R525(ACRO)KF
Basic UDI-DI: B-IINA-R525(ACRO)KF
Reference: IINA-R525
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 11.08.2026 23:31

Manufacturer products Authorised representative products Authorised representative actors View details

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

IDAB4212

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-IDAB421Q9
Basic UDI-DI: B-IDAB421Q9
Reference: IDAB4212
EMDN: W0105099007
EMDN description: DENGUE - RT & POC
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 10.08.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 Antigen Rapid Test Cassette (Nasal Swab)

ICOVu002

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-ICOVu00A4
Basic UDI-DI: B-ICOVu00A4
Reference: ICOVu002
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 08.08.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 Antigen Rapid Test Cassette (Saliva)

ICOV7002

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-ICOV700Z9
Basic UDI-DI: B-ICOV700Z9
Reference: ICOV7002
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 08.08.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 IgG/IgM Rapid Test

ICOV4212

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-ICOV421Z2
Basic UDI-DI: B-ICOV421Z2
Reference: ICOV4212
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 08.08.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

COVID-19 Neutralization Antibody Rapid Test Cassette (WB/S/P)

ICNA4002

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-ICOV400YS
Basic UDI-DI: B-ICOV400YS
Reference: ICNA4002
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 08.08.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

Chikungunya IgG/IgM Rapid Test

ICHI4212

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hangzhou Clongene Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000030069
UDI-DI: D-ICHI421TS
Basic UDI-DI: B-ICHI421TS
Reference: ICHI4212
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 08.08.2026 22:50

Manufacturer products Authorised representative products Authorised representative actors View details

Hyrespira 5-in-1 Rapid Test

Multiple Models

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Heyer Medical AG
Manufacturer SRN: DE-MF-000014330
UDI-DI: 04251743800549
Basic UDI-DI: 4251743800016UW
Reference: 140003
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Safety summary (SSCP/SSP): HY-123143-PVP-014 · Rev. A/2
Authorised representative: -
Last updated: 08.08.2026 13:39

Manufacturer products Open in EUDAMED View details

Hyrespira 5-in-1 Rapid Test

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Heyer Medical AG
Manufacturer SRN: DE-MF-000014330
UDI-DI: 04251743800556
Basic UDI-DI: 4251743800016UW
Reference: 140004
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: -
Safety summary (SSCP/SSP): HY-123143-PVP-014 · Rev. A/2
Authorised representative: -
Last updated: 08.08.2026 13:37

Manufacturer products Open in EUDAMED View details

Hyrespira 5-in-1 Rapid Test

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Heyer Medical AG
Manufacturer SRN: DE-MF-000014330
UDI-DI: 04251743800563
Basic UDI-DI: 4251743800016UW
Reference: 140005
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: -
Safety summary (SSCP/SSP): HY-123143-PVP-014 · Rev. A/2
Authorised representative: -
Last updated: 08.08.2026 13:37

Manufacturer products Open in EUDAMED View details

Hyrespira 5-in-1 Rapid Test

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitReagentSelf testingSingle use

Manufacturer: Heyer Medical AG
Manufacturer SRN: DE-MF-000014330
UDI-DI: 04251743800570
Basic UDI-DI: 4251743800016UW
Reference: 140006
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: -
Safety summary (SSCP/SSP): HY-123143-PVP-014 · Rev. A/2
Authorised representative: -
Last updated: 08.08.2026 13:37

Manufacturer products Open in EUDAMED 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

Monkeypox Virus Antigen Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-IMXG-ACO402FM
Basic UDI-DI: B-IMXG-ACO402FM
Reference: IMXG-ACO402
EMDN: W0105099008
EMDN description: MONKEYPOX VIRUS / MPOX RT & POC
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