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Radio Frequency Surgical Systems-Electrodes

by MedSphere International (Shanghai) Co., Ltd. 194 variants

Ref L-243

Active European Union

CE MDD

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 25 Oct 2026. What this means

Overview

For the Radio Frequency Surgical Systems-Electrodes, a medical device used in surgical procedures, the instructions and guidelines for safe use must be followed closely. The device's primary function is to emit radio frequency energy, which is then applied to tissues to reduce bleeding and promote healing.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06938775205563 Basic UDI-DI 06938775205563UDI-DIDate3 May 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  • Withdrawn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/MDD Active

Specification

EUDAMED

Model / Reference
L-243
Primary DI / UDI-DI
06938775205563
Basic UDI-DI
B-06938775205563
EMDN Code
K02030101 Radiofrequency surgery electrodes, single-use
Device Class
Class IIb
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000033808
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from MedSphere International (Shanghai) Co., Ltd.

See all devices from MedSphere International (Shanghai) Co., Ltd. →

Properties

  • Sterile

Other properties (10)

  • 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