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Cryostainer

by X-ZELL Biotech Pte. Ltd. Singapore EUDAMED

Ref XZ1023 EMDN W02010299

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number++G580XZELLCryostainerB3R 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  • Withdrawn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
Cryostainer & Accessories
Model / Reference
XZ1023
Primary DI / UDI-DI
++G580XZELLCryostainerB3R1
Basic UDI-DI
++G580XZELLCryostainerB3R
Direct Marketing DI
++G580XZELLCryostainerB3R1
EMDN Code
W02010299 Immunochemistry 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 ad18f73b-9d18-4ac1-bb4f-543bf7e72367 61 fields · synced 22 Oct 2026