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RealStar® Pneumocystis jirovecii PCR Kit 1.0

by altona Diagnostics GmbH

Ref 551013

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-DEMF0000183795510135V Basic UDI-DI D-DEMF0000183795510135VUDI-DIDate1 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  • Withdrawn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

Device Name
RealStar® Pneumocystis jirovecii PCR Kit 1.0
Model / Reference
551013
Primary DI / UDI-DI
D-DEMF0000183795510135V
Basic UDI-DI
B-DEMF0000183795510135V
EMDN Code
W0105060499 Mycology na reagents - other
Device Class
Class IVD General
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000018379

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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