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Ad-2126

by Andon Health Co., Ltd.

Ref AD-2126, /

Active European Union

CE MDR 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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD Number69302518TENS04NY Basic UDI-DI Date11 Feb 2026RegisteredStatusActive
European UnionCE/MDR Number69302518TENS04NY Basic UDI-DI Date11 Feb 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  • Withdrawn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, CE/MDR Active

Specification

EUDAMED

Trade Name
Ad-2126
Tens
Ad-2126(Ad-2126)
Device Name
Transcutaneous Electrical Nerve Stimulators (TENS Device)
Model / Reference
AD-2126, /
Primary DI / UDI-DI
06930251800996, 06930251803768
Basic UDI-DI
69302518TENS04NY, B-06930251800996
EMDN Code
Z12062899, Z12101106
Device Class
Class IIa
EU market of registration
Poland
France

Manufacturer details

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

Other devices from Andon Health Co., Ltd.

See all devices from Andon Health Co., Ltd. →

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