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Electrode pad

by GMDASZ Manufacturing Co., Ltd. 40 variants

Ref 615090-BModel CWNXXXX(OCWNXXXX) series, CWTXXXX series,CWFXXXX series, DWNXXXX series, DWTXXXX series,DWFXXXX series,QWNXXXX series,QWTXXXX series,QWFXXXX series, ACWNXXXX(AWNXXXX, OACWNXXXX) series, ACWTXXXX series，ACWFXXXX(AWFXXXX) series, ACWWXXXX(ACGWXXXX)series

Electrode pad (615090-B) is a Class I device made by Gmdasz Manufacturing Co., Ltd., registered in EUDAMED on 11 Mar 2026 (Basic UDI-DI 697034167099HN), active as of 7 Nov 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697034167099HN Basic UDI-DI 06970341673925UDI-DIDate11 Mar 2026RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
CWNXXXX(OCWNXXXX) series, CWTXXXX series, CWFXXXX series, DWNXXXX series, DWTXXXX series, DWFXXXX series, QWNXXXX series, QWTXXXX series, QWFXXXX series, ACWNXXXX(AWNXXXX, OACWNXXXX) series, ACWTXXXX series，ACWFXXXX(AWFXXXX) series, ACWWXXXX(ACGWXXXX)series, 615090-B
Primary DI / UDI-DI
06970341673925
Basic UDI-DI
697034167099HN
EMDN code
N010201 Tens system electrodes
Device class
Class I
EU registration type
Standard device
EU market of registration
Netherlands

Manufacturer details

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

Similar devices in this category

Other devices filed under TENS SYSTEM ELECTRODES.

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Properties

Other properties (14, all answered No)