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electrode pad
EUDAMEDFDA UDIClass I (EU MDR)
Ref QSN2c27Model CSNXXXX series, CSFXXXX series, DSNXXXX series, ACSNXXXX series, LXXXX series,QSNXXXX series, PCSXXXX series， PCSNXXXX series
Identity
- Trade Name
- electrode pad EUDAMEDNA FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, reusable FDA UDI
- Device Name
- Electrode pad EUDAMED
- Model / Reference
- CSNXXXX series, CSFXXXX series, DSNXXXX series, ACSNXXXX series, LXXXX series,QSNXXXX series, PCSXXXX series， PCSNXXXX series EUDAMEDQSN2c27 EUDAMEDSBM1AD002 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970341670894 EUDAMEDFDA UDI
- Basic UDI-DI
- 697034167265HF EUDAMED
- 510(k) Number
- K160138 FDA UDI
- FDA Product Code
- GXY FDA UDI
- EMDN Code
- N010201 TENS SYSTEM ELECTRODES EUDAMED
- GMDN Term
- Transcutaneous electrical stimulation electrode, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
electrode pad by Gmdasz Manufacturing Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697034167265HF | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- GMDASZ Manufacturing Co., Ltd.
- EUDAMED SRN
- CN-MF-000011760
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (2)
- EUDAMED 1af787d8-c470-449e-974c-b42b0e68f281 61 fields · synced Jun 19, 2026
- FDA UDI bb7c7073-95f7-49c8-8e71-6ce8241ade76 33 fields · synced May 30, 2026