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Cryophore™ Pleural Fluid 1

by X-ZELL Biotech Pte. Ltd. Singapore EUDAMED

Ref XZ3001 EMDN W0103010301

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number++G580XZ30012R Basic UDI-DIDate6 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Cryophore™ Pleural Fluid 1
Model / Reference
XZ3001
Primary DI / UDI-DI
G580XZ30011E
Basic UDI-DI
++G580XZ30012R
Direct Marketing DI
G580XZ30011E
EMDN Code
W0103010301 Histo / cyto stains
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
SG-MF-000039227
Authorised representative
X-ZELL Biotech GmbH DE-AR-000039132

Other devices from X-ZELL Biotech Pte. Ltd.

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
  • New Device
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 1d42d964-02c0-42c6-b691-fe965cea4f7b 61 fields · synced 22 Oct 2026