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Pneumo CEL Indirect IFA

by Cellabs Pty Ltd

Ref KP2Model Pneumo CEL Indirect IFA (50T)

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-KP2D7 Basic UDI-DI D-KP2D7UDI-DIDate17 Jun 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  • Withdrawn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
Pneumo CEL Indirect IFA (50T), KP2
Primary DI / UDI-DI
D-KP2D7
Basic UDI-DI
B-KP2D7
EMDN Code
W0104050201 Pneumocystis jirovecii (pneumocystis carinii)
Device Class
Class IVD General
EU market of registration
Portugal

Manufacturer details

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

From the manufacturer

Manufacturer's product page: SS-R1

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See all devices from Cellabs Pty Ltd →

Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (7)

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