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electrode pad

by GMDASZ Manufacturing Co., Ltd. 9 variants

Ref 8703708Model CSNXXXX series, CSFXXXX series, DSNXXXX series, ACSNXXXX series, LXXXX series,QSNXXXX series, PCSXXXX series， PCSNXXXX series

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06970341670887 UDI-DI Date8 Apr 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697034167265HF Basic UDI-DI 06970341670887UDI-DIDate12 Mar 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Transcutaneous electrical stimulation electrode, reusable
Model / Reference
CSNXXXX series, CSFXXXX series, DSNXXXX series, ACSNXXXX series, LXXXX series, QSNXXXX series, PCSXXXX series， PCSNXXXX series, 8703708
Primary DI / UDI-DI
06970341670887
Basic UDI-DI
697034167265HF
510(k) Number
FDA Product Code
GXY
EMDN Code
N010201 Tens system electrodes
GMDN Term
Transcutaneous electrical stimulation electrode, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
882.1320
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000011760
Authorised representative
Wellkang Ltd XI-AR-000001836

Other devices from Gmdasz Manufacturing Co., Ltd.

See all devices from Gmdasz Manufacturing Co., Ltd. →

Properties

  • Prescription Use
  • Over-the-Counter
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

  • Sterile: No
  • Single Use: 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
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No