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INNODX f-PSA CMIA

by Xiamen Innodx Biotech Co., Ltd. 5 variants

Ref KR-f-PSA-0150

Active European Union

CE IVDR

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697360079023JT Basic UDI-DI 06973600799251UDI-DIDate5 May 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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Model / Reference
KR-f-PSA-0150
Primary DI / UDI-DI
06973600799251
Basic UDI-DI
697360079023JT
EMDN Code
W0102030114 Free prostatic specific antigen
Device Class
Class C
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
CN-MF-000041071
Authorised representative
QbD RepS BV BE-AR-000000040

Other devices from Xiamen Innodx Biotech Co., Ltd.

See all devices from Xiamen Innodx Biotech Co., Ltd. →

Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (8)

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