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Plasma Surgery System

by Chengdu Mechan Electronic Technology Co., Ltd. China EUDAMED

Ref PLA-700

EMDN Z12010905

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06952249090011 Basic UDI-DIDate22 Apr 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 24 Oct 2026

Device Name
Plasma Surgery System
Model / Reference
PLA-700
Primary DI / UDI-DI
06952249090011
Basic UDI-DI
B-06952249090011
EMDN Code
Z12010905 Radiosurgical units
Device Class
Class IIb
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000032466
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Chengdu Mechan Electronic Technology Co., Ltd.

See all devices from Chengdu Mechan Electronic Technology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Reusable
Other properties (10)
  • Sterile: No
  • Implantable: 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 42651904-043b-4af4-87d9-c27fbf20f9b8 61 fields · synced 24 Oct 2026