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Open-surgery electrosurgical handpieces / electrodes

by Zhejiang Medstar Technology Co., Ltd. China EUDAMED

Ref EKS01-63EModel PS

EMDN K0201010201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697215505PS001DX Basic UDI-DIDate23 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Open-surgery electrosurgical handpieces / electrodes
Model / Reference
PS, EKS01-63E
Primary DI / UDI-DI
06972155052453
Basic UDI-DI
697215505PS001DX
Direct Marketing DI
06972155052453
EMDN Code
K0201010201 Open electrosurgery dissectors, single-use
Device Class
Class IIb
Market of Registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000028154
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Zhejiang Medstar Technology Co., Ltd.

See all devices from Zhejiang Medstar Technology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 519c02fe-56fa-48e5-a955-bf315b6533b7 61 fields · synced 23 Oct 2026