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Tesmed

by Famidoc Technology Co., Ltd. EUDAMED

Active European Union

Ref FDES116

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697038963FDESD3N8 Basic UDI-DIDate10 Oct 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • CN23/00003635 Amended

    Quality management system EU MDR

    Notified body
    Notified body 1639
    Issued
    30 Sep 2024
    Expires
    10 Jul 2028
    Reason
    Mnf ar change

Specification

EUDAMED

Device Name
Electrical stimulator
Model / Reference
FDES116
Primary DI / UDI-DI
06970389631673
Basic UDI-DI
697038963FDESD3N8
EMDN Code
N010103 Bipolar nervous electrostimulators, battery-powered
Device Class
Class IIa
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000016603
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Famidoc Technology Company Limited

See all devices from Famidoc Technology Company Limited →

Properties

Other properties (13)

  • Sterile: No
  • 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