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electrode pad
EUDAMEDFDA UDIClass I (EU MDR)
Ref DWN610Model 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)seriesRef 8703708_sModel CSNXXXX series, CSFXXXX series, DSNXXXX series, ACSNXXXX series, LXXXX series,QSNXXXX series, PCSXXXX series， PCSNXXXX seriesRef 8703708Ref CWN2305Ref CWF2509Ref CWN1007HRef BSN2505Ref ACWN2718(G)Ref CWN1003Ref ACWN2713(A)Ref PSN2505Ref CWT2510Ref CWF2505Ref PSN2510DRef CWN1005Ref ACWN2713(R)
Identity
- Trade Name
- electrode pad EUDAMEDNA FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, reusable FDA UDI
- Device Name
- Electrode pad EUDAMEDCWT2510, electrode pad, 5x10cm, tan tricot FDA UDICWF2509, electrode pad, white foam FDA UDI4pcs per pack FDA UDICWN1005, electrode pad, white cloth FDA UDIelectrode pad, 50x50mm square, prewired, foam backing FDA UDI
- 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 EUDAMEDDWN610 EUDAMEDCSNXXXX series, CSFXXXX series, DSNXXXX series, ACSNXXXX series, LXXXX series,QSNXXXX series, PCSXXXX series， PCSNXXXX series EUDAMED8703708_s EUDAMED8703708 EUDAMEDCWN1003 EUDAMEDFDA UDICWF2505 EUDAMEDFDA UDICWN2305 EUDAMEDCWF2509 EUDAMEDCWN1007H EUDAMEDBSN2505 EUDAMEDACWN2718(G) EUDAMEDACWN2713(A) EUDAMEDPSN2505 EUDAMEDCWT2510 EUDAMEDPSN2510D EUDAMEDCWN1005 EUDAMEDACWN2713(R) EUDAMEDNA FDA UDI
- Description
- CWT2510, electrode pad, 5x10cm, tan tricot FDA UDICWF2509, electrode pad, white foam FDA UDI4pcs per pack FDA UDICWN1005, electrode pad, white cloth FDA UDIelectrode pad, 50x50mm square, prewired, foam backing FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970341673765 EUDAMED06970341673833 EUDAMED06970341670887 EUDAMED06970341670276 EUDAMEDFDA UDI06970341670337 EUDAMEDFDA UDI06970341670023 EUDAMEDFDA UDI06970341670221 EUDAMEDFDA UDI06970341670054 EUDAMEDFDA UDI06970341673543 EUDAMED06970341670641 EUDAMED06970341673581 EUDAMED06970341672270 EUDAMED06970341672348 EUDAMED06970341673550 EUDAMED06970341673574 EUDAMED06970341672300 EUDAMED
- Basic UDI-DI
- 697034167099HN EUDAMED697034167265HF EUDAMED
- 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 EUDAMEDSpain EUDAMEDGermany EUDAMEDNetherlands 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 | 697034167099HN | 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 (21)
- EUDAMED 8ee73982-9057-48b6-83ac-eb945911ddf1 61 fields · synced Aug 4, 2026
- EUDAMED 57949504-3978-44a4-8356-98019ba028ab 61 fields · synced May 18, 2026
- EUDAMED a24a0b04-571c-4bc2-8e37-247355b34951 61 fields · synced May 18, 2026
- FDA UDI 1a042fca-8f7c-483a-8bbc-50ef2a782b86 34 fields · synced May 25, 2026
- FDA UDI a733e3a0-214a-4a8b-af02-4710c337b881 34 fields · synced May 30, 2026
- FDA UDI d649fdba-b10f-4e8a-844c-60056c4f602a 33 fields · synced May 30, 2026
- FDA UDI 08de3ea6-bd46-4319-bfc0-679cae22f8fd 34 fields · synced May 30, 2026
- FDA UDI 1e7d58c3-29ec-44bb-a692-aeea1ea0ece8 34 fields · synced May 30, 2026
- EUDAMED c0c05a29-9b34-4932-8ca0-1bea7d97b905 61 fields · synced Jun 18, 2026
- EUDAMED b91e02d0-325f-4af9-8938-f8a6621d0e11 61 fields · synced Jul 9, 2026
- EUDAMED 28a9e700-03db-4295-b007-b226f93e1682 61 fields · synced Jul 11, 2026
- EUDAMED d6ff1284-dacc-49d3-8a95-c7d75b9b90c8 61 fields · synced Jul 14, 2026
- EUDAMED 457c1bef-da89-4e5e-a542-fcbee52d6d51 61 fields · synced Jul 15, 2026
- EUDAMED e318b2d9-b7bf-4456-a277-b765d39394df 61 fields · synced Jul 16, 2026
- EUDAMED 5e8197d5-cdc6-4691-b550-7c915c28f12f 61 fields · synced Jul 18, 2026
- EUDAMED 1fa16c41-9406-49af-9f2e-640097821449 61 fields · synced Jul 19, 2026
- EUDAMED 7c51d780-c21c-41f4-a896-923f345fdc49 61 fields · synced Jul 20, 2026
- EUDAMED 0012d451-bf26-4020-a511-7607fa3f7583 61 fields · synced Jul 24, 2026
- EUDAMED 9c724742-2912-43eb-89f8-3863f895df4c 61 fields · synced Jul 30, 2026
- EUDAMED ae66d584-bd74-4f4d-8a1b-f182fc741f0d 61 fields · synced Aug 3, 2026
- EUDAMED e213e27b-0700-4406-83c8-d71db5f4115e 61 fields · synced Aug 4, 2026