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Sterile Co-Ablation Probe

by Hygea Medical Technology Co., Ltd. 12 variants

Model Elite(RAL30/RAS30/RBL26/RAL26/RBS26/RAS26/RBL20/RBS20/RCL17/RCS17/ABL20/ABS20/ACL17/ACS17), Elite RAS26

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69356506KBD0060G4 Basic UDI-DI 06935650600611UDI-DIDate24 Oct 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Sterile Co-Ablation Probe
Cryosurgical Probe
Model / Reference
Elite(RAL30/RAS30/RBL26/RAL26/RBS26/RAS26/RBL20/RBS20/RCL17/RCS17/ABL20/ABS20/ACL17/ACS17), Elite RAS26
Primary DI / UDI-DI
06935650600611
Basic UDI-DI
69356506KBD0060G4, B-06935650600611
EMDN Code
Z120102 Cryosurgery equipment
Device Class
Class IIa
Class IIb
EU market of registration
Czechia

Manufacturer details

EUDAMED SRN
CN-MF-000023128
Authorised representative
Wellkang Ltd XI-AR-000001836

Other devices from Hygea Medical Technology Co., Ltd.

See all devices from Hygea Medical Technology Co., Ltd. →

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