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Sem 27 (867.00)(Ad-2128)

by Andon Health Co., Ltd. China EUDAMED

Ref AD-2128

EMDN Z12062801

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69302518TENS04NY Basic UDI-DIDate11 Feb 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Transcutaneous Electrical Nerve Stimulators (TENS Device)
Model / Reference
AD-2128
Primary DI / UDI-DI
06930251802815
Basic UDI-DI
69302518TENS04NY
Direct Marketing DI
06930251802815
EMDN Code
Z12062801 Muscle reinforcement stimulators for innervated muscles
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000001799
Authorised representative
iHealthLabs Europe FR-AR-000000340

Other devices from Andon Health Co., Ltd.

See all devices from Andon Health 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 03f0d555-31a4-4f07-9426-8700a6af0220 61 fields · synced 22 Oct 2026