Electrode pad
by GMDASZ Manufacturing Co., Ltd. 40 variants
Ref 610034-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 (610034-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
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697034167099HN 06970341673963 | Date11 Mar 2026 | StatusActive |
Official records
- EUDAMED public site 697034167099HN
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- 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, 610034-B
- Primary DI / UDI-DI
- 06970341673963
- 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
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