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Cryofixator

by X-ZELL Biotech Pte. Ltd. Singapore EUDAMED

Ref XZ1022 EMDN W0299

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number++G580XZELLCryofixatorBXK Basic UDI-DIDate22 Dec 2023RegisteredStatusActive

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  • Withdrawn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
Cryofixator & Accessories
Model / Reference
XZ1022
Primary DI / UDI-DI
++G580XZELLCryofixatorBXK1
Basic UDI-DI
++G580XZELLCryofixatorBXK
Direct Marketing DI
++G580XZELLCryofixatorBXK1
EMDN Code
W0299 IVD instruments - other
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
  • Surgical Instrument
  • New Device
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No

Sources (1)

  • EUDAMED e4cc0176-259a-4eca-9ab9-1c664fc2ddfd 61 fields · synced 22 Oct 2026