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PAXgene

by PreAnalytiX GmbH

Ref 768165

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number4053727FBROCKIYX7 Basic UDI-DI 04053727681652UDI-DIDate10 Jun 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  • Withdrawn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

Device Name
PAXgene® Blood ccfDNA Tube
Model / Reference
768165
Primary DI / UDI-DI
04053727681652
Basic UDI-DI
4053727FBROCKIYX7
EMDN Code
W050101010201 Blood collection, tubes with additives or serum separator
Device Class
Class A
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
CH-MF-000033445
Authorised representative
QIAGEN GmbH DE-AR-000004971

Other devices from Preanalytix GmbH

Properties

  • Sterile
  • Animal Tissues
  • Professional Testing

Other properties (8)

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