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Syphilis Ab Rapid Test Cassette (Serum/Plasma)

by HEALSTONE Biotech Inc.

Ref GCSYP-302a

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-GCSYP-302aHSNJ Basic UDI-DI D-GCSYP-302aHSNJUDI-DIDate4 Sep 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  • Withdrawn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
GCSYP-302a
Primary DI / UDI-DI
D-GCSYP-302aHSNJ
Basic UDI-DI
B-GCSYP-302aHSNJ
EMDN Code
W0105090105 Syphilis - rt & poc
Device Class
Class IVD General
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CA-MF-000057743
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Healstone Biotech Inc.

Properties

  • Animal Tissues
  • Professional Testing

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