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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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SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ISIC-ACOR525JU
Basic UDI-DI: B-ISIC-ACOR525JU
Reference: ISIC-ACOR525
EMDN: W0105090601
EMDN description: CORONAVIRUS / INFLUENZA - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.08.2026 06:52

Manufacturer products Authorised representative products Authorised representative actors View details

D-IMVD-645M6

Norovirus+Rotavirus+Adenovirus+Astrovirus Combo Rapid Test Cassette (Feces)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: CITEST DIAGNOSTICS INC
Manufacturer SRN: CA-MF-000022516
UDI-DI: D-IMVD-645M6
Basic UDI-DI: B-IMVD-645M6
Reference: IMVD-645
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.08.2026 06:52

Manufacturer products Authorised representative products Authorised representative actors View details

H. pylori Antibody Rapid Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-IHP-R402(ACRO)36
Basic UDI-DI: B-IHP-R402(ACRO)36
Reference: IHP-R402
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.08.2026 06:52

Manufacturer products Authorised representative products Authorised representative actors View details

D-IHP-602(CT)BS

H.pylori Antigen Rapid Test Cassette (Feces)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: CITEST DIAGNOSTICS INC
Manufacturer SRN: CA-MF-000022516
UDI-DI: D-IHP-602(CT)BS
Basic UDI-DI: B-IHP-602(CT)BS
Reference: IHP-602(CT)
EMDN: W0105090102
EMDN description: H. PYLORI - RT & POC
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.08.2026 06:52

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D-ICD-635B(CT)XM

Clostridium difficile GDH+ Toxin A +Toxin B Combo Rapid Test Cassette (Feces)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: CITEST DIAGNOSTICS INC
Manufacturer SRN: CA-MF-000022516
UDI-DI: D-ICD-635B(CT)XM
Basic UDI-DI: B-ICD-635B(CT)XM
Reference: ICD-635B(CT)
EMDN: W0105090106
EMDN description: CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.08.2026 06:52

Manufacturer products Authorised representative products Authorised representative actors View details

D-ICAM-6029U

Campylobacter Rapid Test Cassette (Feces)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: CITEST DIAGNOSTICS INC
Manufacturer SRN: CA-MF-000022516
UDI-DI: D-ICAM-6029U
Basic UDI-DI: B-ICAM-6029U
Reference: ICAM-602
EMDN: W0105090199
EMDN description: BACTERIOLOGY - RT & POC - OTHER
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.08.2026 06:52

Manufacturer products Authorised representative products Authorised representative actors View details

LH Ovulation Rapid Test Midstream

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-FLH-103H(ACRO)7Y
Basic UDI-DI: B-FLH-103H(ACRO)7Y
Reference: FLH-103H
EMDN: W0102160304
EMDN description: LH - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.08.2026 06:52

Manufacturer products Authorised representative products Authorised representative actors View details

iGFBP-1 Rapid Test Dipstick

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-FIG-501(ACRO)WA
Basic UDI-DI: B-FIG-501(ACRO)WA
Reference: FIG-501
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.08.2026 06:52

Manufacturer products Authorised representative products Authorised representative actors View details

hCG Pregnancy Enhanced Sensitivity Rapid Test Midstream

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-FHC-U103H(ACRO)QV
Basic UDI-DI: B-FHC-U103H(ACRO)QV
Reference: FHC-U103H
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.08.2026 06:52

Manufacturer products Authorised representative products Authorised representative actors View details

hCG Pregnancy Rapid Test Midstream

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-FHC-103H(ACRO)UY
Basic UDI-DI: B-FHC-103H(ACRO)UY
Reference: FHC-103H
EMDN: W0102160302
EMDN description: HCG - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.08.2026 06:52

Manufacturer products Authorised representative products Authorised representative actors View details

SCOP Rapid Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-DSC-ACOR102ZE
Basic UDI-DI: B-DSC-ACOR102ZE
Reference: DSC-ACOR102
EMDN: W0102160599
EMDN description: DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.08.2026 06:52

Manufacturer products Authorised representative products Authorised representative actors View details

Codeine (COD) Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-DCOD-ACO114R5
Basic UDI-DI: B-DCOD-ACO114R5
Reference: DCOD-ACO114
EMDN: W0102160508
EMDN description: OPIATES - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.08.2026 06:52

Manufacturer products Authorised representative products Authorised representative actors View details

Codeine (COD) Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-DCOD-ACO111QX
Basic UDI-DI: B-DCOD-ACO111QX
Reference: DCOD-ACO111
EMDN: W0102160508
EMDN description: OPIATES - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.08.2026 06:52

Manufacturer products Authorised representative products Authorised representative actors View details

Codeine (COD) Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-DCOD-ACO102QW
Basic UDI-DI: B-DCOD-ACO102QW
Reference: DCOD-ACO102
EMDN: W0102160508
EMDN description: OPIATES - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.08.2026 06:52

Manufacturer products Authorised representative products Authorised representative actors View details

Codeine (COD) Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-DCOD-ACO101QU
Basic UDI-DI: B-DCOD-ACO101QU
Reference: DCOD-ACO101
EMDN: W0102160508
EMDN description: OPIATES - RT & POC
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 13.08.2026 06:52

Manufacturer products Authorised representative products Authorised representative actors View details

Wondfo Carcinoembryonic Antigen (CLIA)

Carcinoembryonic Antigen (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Tisenc Medical Devices Co., Ltd.
Manufacturer SRN: CN-MF-000022936
UDI-DI: 06971824209068
Basic UDI-DI: B-06971824209068
Reference: F141C
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Greece
Authorised representative: QbD RepS BV
Last updated: 13.08.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details

Wondfo Alpha-fetoprotein (CLIA)

Alpha-fetoprotein (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Tisenc Medical Devices Co., Ltd.
Manufacturer SRN: CN-MF-000022936
UDI-DI: 06971824208986
Basic UDI-DI: B-06971824208986
Reference: F76C
EMDN: W0102030199
EMDN description: CANCER ANTIGENS - OTHER
First on market country: Cyprus
Authorised representative: QbD RepS BV
Last updated: 13.08.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details

Wondfo Carcinoembryonic Antigen (CLIA)

Carcinoembryonic Antigen (CLIA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Tisenc Medical Devices Co., Ltd.
Manufacturer SRN: CN-MF-000022936
UDI-DI: 06971824209051
Basic UDI-DI: B-06971824209051
Reference: F141A
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Greece
Authorised representative: QbD RepS BV
Last updated: 13.08.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details

Wondfo Alpha-fetoprotein (CLIA)

Alpha-fetoprotein (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Tisenc Medical Devices Co., Ltd.
Manufacturer SRN: CN-MF-000022936
UDI-DI: 06971824208979
Basic UDI-DI: B-06971824208979
Reference: F76A
EMDN: W0102030199
EMDN description: CANCER ANTIGENS - OTHER
First on market country: Cyprus
Authorised representative: QbD RepS BV
Last updated: 13.08.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details

Wondfo Alpha-fetoprotein (CLIA)

Alpha-fetoprotein (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Tisenc Medical Devices Co., Ltd.
Manufacturer SRN: CN-MF-000022936
UDI-DI: 06971824208962
Basic UDI-DI: B-06971824208962
Reference: F60C
EMDN: W0102030199
EMDN description: CANCER ANTIGENS - OTHER
First on market country: Cyprus
Authorised representative: QbD RepS BV
Last updated: 13.08.2026 06:48

Manufacturer products Authorised representative products Authorised representative actors View details