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CryoSure-DEX40

by WAK-Chemie Medical GmbH

Ref WAK-DEX40-25

Active European Union

CE MDR

Valid until

25 Sep 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier DNV MEDCERT GmbH

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/MDR Number426026693CryoSureSoluti55 Basic UDI-DI 04260266930039UDI-DIDate7 Aug 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 20445GB450250925 Active

    Technical documentation EU MDR

    Certifier
    DNV MEDCERT GmbH 0482
    Issued
    25 Sep 2025
    Expires
    25 Sep 2030

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
CryoSure
Model / Reference
WAK-DEX40-25
Primary DI / UDI-DI
04260266930039
Basic UDI-DI
426026693CryoSureSoluti55
Direct Marketing DI
04260266930039
EMDN Code
B99 Haematology and haemotransfusion devices - other
Device Class
Class III
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000016551

Other devices from WAK-Chemie Medical GmbH

  • CryoSure-DMSO

    Class III

  • CryoSure-DMSO

    Class III

  • CryoSure-DMSO

    Class III

Properties

  • Sterile

Other properties (12)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No