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Sterile Microwave Ablation Probe

by Hygea Medical Technology Co., Ltd. EUDAMED

Active European Union

Model Exact (HP-1805080E/HP-1605100E/HP-1507200E/HP-1512200/HC-1814100E/HC-1814150E/HC-1814200E/HC-1614150E/HC-1614200E/HC-1514150E/HC-1514200E/HC-1414250E/HS-1425150E/HS-1425200E/HT-1414200E)

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69356506PMA0280NP Basic UDI-DIDate23 Oct 2024RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Sterile Microwave Ablation Probe
Model / Reference
Exact (HP-1805080E/HP-1605100E/HP-1507200E/HP-1512200/HC-1814100E/HC-1814150E/HC-1814200E/HC-1614150E/HC-1614200E/HC-1514150E/HC-1514200E/HC-1414250E/HS-1425150E/HS-1425200E/HT-1414200E)
Primary DI / UDI-DI
06935650622521
Basic UDI-DI
69356506PMA0280NP
EMDN Code
Z120608 Microwave therapy equipment
Device Class
Class IIb
Market of Registration
Spain

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
  • Measuring Function

Other properties (11)

  • 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
  • Incorporates Medicinal Product: No