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Open-surgery electrosurgical handpieces / electrodes

by Zhejiang Medstar Technology Co., Ltd. 463 variants

Ref ENM02-100E-AModel PS

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697215505PS001DX Basic UDI-DI 06972155054457UDI-DIDate23 Apr 2026RegisteredStatusActive

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  • Withdrawn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
Open-surgery electrosurgical handpieces / electrodes
Model / Reference
PS, ENM02-100E-A
Primary DI / UDI-DI
06972155054457
Basic UDI-DI
697215505PS001DX
Direct Marketing DI
06972155054457
EMDN Code
K0201010301 Open electrosurgery electrodes, single-use
Device Class
Class IIb
EU 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

  • 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