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897 device results listed.

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Influenza A/B+H1N1+H5N1 Antigen Combo Rapid Test

Influenza A/B+H1N1+H5N1 Antigen Combo Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-IINA5-ACO535ZB
Basic UDI-DI: B-IINA5-ACO535ZB
Reference: IINA5-ACO535
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:09

Manufacturer products Authorised representative products Authorised representative actors View details

H5N1 Antigen Rapid Test

H5N1 Antigen Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-IH5N-ACO502NV
Basic UDI-DI: B-IH5N-ACO502NV
Reference: IH5N-ACO502
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:09

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue IgG/IgM Combo Rapid Test

Dengue IgG/IgM Combo Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-IDEN-425(SL)G7
Basic UDI-DI: B-IDEN-425(SL)G7
Reference: IDEN-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 23:08

Manufacturer products Authorised representative products Authorised representative actors View details

Dengue Combo Rapid Test

Dengue Combo Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-IDEC-ACO435PT
Basic UDI-DI: B-IDEC-ACO435PT
Reference: IDEC-ACO435
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:08

Manufacturer products Authorised representative products Authorised representative actors View details

Chikungunya IgM Rapid Test Cassette

Chikungunya IgM Rapid Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ICKM-402(ACRO)LA
Basic UDI-DI: B-ICKM-402(ACRO)LA
Reference: ICKM-402
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:08

Manufacturer products Authorised representative products Authorised representative actors View details

HSV 2 IgG/IgM Test Cassette

HSV 2 IgG/IgM Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ACO-HSV2-402X2
Basic UDI-DI: B-ACO-HSV2-402X2
Reference: ACO-HSV2-402
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:06

Manufacturer products Authorised representative products Authorised representative actors View details

HSV 1 IgG/IgM Test Cassette

HSV 1 IgG/IgM Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ACO-HSV1-402WP
Basic UDI-DI: B-ACO-HSV1-402WP
Reference: ACO-HSV1-402
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:06

Manufacturer products Authorised representative products Authorised representative actors View details

Yellow Fever Virus IgG/IgM Rapid Test

-

IVD generalNot specifiedOn the marketSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-IYF-ACO40287
Basic UDI-DI: B-IYF-ACO40287
Reference: IYF-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 06:46

Manufacturer products Authorised representative products Authorised representative actors View details

HEV Antigen Rapid Test

HEV Antigen Rapid Test

IVD generalIVDDOn the marketKitSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-IHE-ACO102ST
Basic UDI-DI: B-IHE-ACO102ST
Reference: IHE-ACO102
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

Influenza A/B + H5N1 Antigen Combo Rapid Test

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

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

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

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

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