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Sterile Co-Ablation Probe

by Hygea Medical Technology Co., Ltd. EUDAMED

Active European Union

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

Regulatory status

as of 26 Oct 2026

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

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD, CE/MDR Active

Certificates: none listed in EUDAMED

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 RBS20
Primary DI / UDI-DI
06935650600635
Basic UDI-DI
69356506KBD0060G4, B-06935650600635
EMDN Code
Z120102 Cryosurgery equipment
Device Class
Class IIa
Class IIb
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

Show 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