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Cryosurgical System

by Hygea Medical Technology Co., Ltd. United States EUDAMED

Ref NAModel AI Epic S40

EMDN Z120102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06935650600857 Basic UDI-DIDate16 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Cryosurgical System
Model / Reference
AI Epic S40, NA
Primary DI / UDI-DI
06935650600857
Basic UDI-DI
B-06935650600857
EMDN Code
Z120102 Cryosurgery equipment
Device Class
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 & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 09970c93-83b7-4914-ba4e-48581f8776b4 61 fields · synced 22 Oct 2026