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Ureaplasma urealyticum / Ureaplasma parvum Multiplex PCR kit

by Astra Biotech GmbH 8 variants

Ref 86-02Model Ureaplasma urealyticum / Ureaplasma parvum Multiplex PCR kit (Form T)

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-04251557100972 Basic UDI-DI 04251557100972UDI-DIDate24 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  • Withdrawn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
Ureaplasma urealyticum / Ureaplasma parvum Multiplex PCR kit
Model / Reference
Ureaplasma urealyticum / Ureaplasma parvum Multiplex PCR kit (Form T), 86-02
Primary DI / UDI-DI
04251557100972
Basic UDI-DI
B-04251557100972
EMDN Code
W010501080303 Ureaplasma detection by na reagents
Device Class
Class IVD General
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000026439

Other devices from Astra Biotech GmbH

See all devices from Astra Biotech GmbH →

Properties

  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (6)

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