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Prostate Specific Antigen (PSA) Rapid Test Cassette (Whole blood/Serum/Plasma)

by Zhejiang Orient Gene Biotech Co., Ltd

Ref GEPSA-402a

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 linked in EUDAMED

A group certificate may exist

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-GEPSA-402a6T Basic UDI-DI D-GEPSA-402a6TUDI-DIDate28 Apr 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
Prostate Specific Antigen (PSA) Rapid Test
Model / Reference
GEPSA-402a
Primary DI / UDI-DI
D-GEPSA-402a6T
Basic UDI-DI
B-GEPSA-402a6T
EMDN Code
W0102160202 Psa - rt & poc
Device Class
Class IVD Annex II List B
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000017965
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Zhejiang Orient Gene Biotech Co., Ltd.

See all devices from Zhejiang Orient Gene Biotech Co., Ltd. →

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