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TENS/EMS Stimulator

by EasyMed Instruments Co., Ltd. China EUDAMED

Ref SaeboStim One (with large wing) EMDN Z12062801

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69428082E04Y3 Basic UDI-DIDate7 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
SaeboStim One (with large wing)
Primary DI / UDI-DI
06942808221192
Basic UDI-DI
69428082E04Y3
EMDN Code
Z12062801 Muscle reinforcement stimulators for innervated muscles
Device Class
Class IIa
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000008905
Authorised representative
mdi Europa GmbH DE-AR-000006218

Other devices from EasyMed Instruments Co., Ltd.

See all devices from EasyMed Instruments Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 67d9b1d5-57d8-41de-8113-e6f1d94b630b 61 fields · synced 24 Oct 2026