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Chlamydia CEL PN IFA

by Cellabs Pty Ltd 2 variants

Ref KC3-B

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-KC3-BTJ Basic UDI-DI D-KC3-BTJUDI-DIDate22 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  • Withdrawn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/IVDD Active

Specification

EUDAMED

Device Name
Chlamydia CEL PN IFA (200T)
Model / Reference
KC3-B
Primary DI / UDI-DI
D-KC3-BTJ
Basic UDI-DI
B-KC3-BTJ
EMDN Code
W0105010112 Chlamydia pneumoniae antigen detection
Device Class
Class IVD Annex II List B
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
AU-MF-000030640
Authorised representative
WMDE B.V. NL-AR-000002062

From the manufacturer

Manufacturer's product page: SS-C1

Other devices from Cellabs Pty Ltd

See all devices from Cellabs Pty Ltd →

Properties

  • Microbial Substances
  • Professional Testing

Other properties (8)

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