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Plasma Bipolar Resection Generator

by Simai Co., Ltd. China EUDAMED

Ref SM20CH

EMDN Z12010904

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06970197924257 Basic UDI-DIDate11 Nov 2024RegisteredStatusActive

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
Plasma Bipolar Resection Generator
Model / Reference
SM20CH
Primary DI / UDI-DI
06970197924257
Basic UDI-DI
B-06970197924257
EMDN Code
Z12010904 Endoscopic electrosurgical units (esu)
Device Class
Class IIb
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000021302
Authorised representative
Wellkang Ltd XI-AR-000001836

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 c498419a-29bd-4f29-8f29-1536540f1cf0 61 fields · synced 22 Oct 2026