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cryoICE® cryoFORM™

by AtriCure, Inc.

Ref CRYOF/A000957-14Model CRYO2/CRYO3/CRYOF

Expiring European Union

CE MDR

Valid until

21 Aug 2027

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08401439000000000000007ZP Basic UDI-DI 10840143908231UDI-DIDate29 Jun 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 752541 Expiring Supplemented Expires in 293 days

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    20 May 2026
    Expires
    21 Aug 2027
    Reason
    Other

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Expiring

Specification

EUDAMED

Device Name
cryoablation probe
Model / Reference
CRYO2/CRYO3/CRYOF, CRYOF/A000957-14
Primary DI / UDI-DI
10840143908231
Basic UDI-DI
08401439000000000000007ZP
EMDN Code
Z120102 Cryosurgery equipment
Device Class
Class III
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000002974
Authorised representative
AtriCure Europe B.V. NL-AR-000000165

Other devices from Atricure, Inc.

See all devices from Atricure, Inc. →

Properties

  • Sterile
  • CMR Substance

Other properties (11)

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