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Strep A Rapid Test Cassette (Throat Swab)

by Healgen Scientific Limited Liability Company

Ref GCSTR-502a, GCSTR-502Ca, GCSTR-502CSa

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-GCSTR-502aHGL7 Basic UDI-DI Date31 Mar 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  • Withdrawn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

Model / Reference
GCSTR-502a, GCSTR-502Ca, GCSTR-502CSa
Primary DI / UDI-DI
D-GCSTR-502aHGL7, D-GCSTR-502CaHGUH, D-GCSTR-502CSaHGAA
Basic UDI-DI
B-GCSTR-502aHGL7, B-GCSTR-502CaHGUH, B-GCSTR-502CSaHGAA
EMDN Code
W0105090103 Strep. a - rt & poc
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

Other devices from Healgen Scientific Limited Liability Company

See all devices from Healgen Scientific Limited Liability Company →

Properties

  • Animal Tissues
  • Professional Testing YesEUDAMEDNoEUDAMED

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No