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COVID-19+Flu A&B+RSV Ag Combo Rapid Test Cassette (Swab)

by Healgen Scientific Limited Liability Company

Ref GCFCR-T525Sa-DD, GCFCR-T525a, 3022401, GCFCR-T525a-NN, GCFR(A)-T502a

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-GCFCR-T525Sa-DDHGJ8 Basic UDI-DI Date1 Apr 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Trade Name
COVID-19+Flu A&B+RSV Ag Combo Rapid Test Cassette (Swab)
COVID-19/Flu A&B/RSV Ag Combo Rapid Test Cassette (Swab)
COVID-19 /Flu A&B /RSV Ag Combo Rapid Test Cassette (Swab)
Flu A/RSV Ag Combo Rapid Test Cassette (Swab)
Model / Reference
GCFCR-T525Sa-DD, GCFCR-T525a, 3022401, GCFCR-T525a-NN, GCFR(A)-T502a
Primary DI / UDI-DI
D-GCFCR-T525Sa-DDHGJ8, D-GCFCR-T525a3T, 69743840313536, D-GCFCR-T525aHGFM, D-GCFCR-T525a-NNHGR9, D-GCFCR-T525a-NNNG, D-GCFCR-T525Sa-DD4H, D-GCFR(A)-T502aMC
Basic UDI-DI
B-GCFCR-T525Sa-DDHGJ8, B-GCFCR-T525a3T, B-69743840313536, B-GCFCR-T525aHGFM, B-GCFCR-T525a-NNHGR9, B-GCFCR-T525a-NNNG, B-GCFCR-T525Sa-DD4H, B-GCFR(A)-T502aMC
EMDN Code
W0105090699, W0105099099
Device Class
Class IVD General
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000018839
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

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Properties

  • Animal Tissues
  • Reagent NoEUDAMEDYesEUDAMED
  • Near-Patient Testing NoEUDAMEDYesEUDAMED
  • Professional Testing

Other properties (6)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No