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Sterile Microwave Ablation Probe

by Hygea Medical Technology Co., Ltd. 13 variants

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)

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 Number69356506PMA0280NP Basic UDI-DI 06935650624228UDI-DIDate23 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  • Withdrawn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 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
06935650624228
Basic UDI-DI
69356506PMA0280NP
EMDN Code
Z120608 Microwave therapy equipment
Device Class
Class IIb
EU 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