Identity
- Trade Name
- Everyway EUDAMEDFDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, reusable FDA UDI
- Device Name
- Cutaneous Electrode Pad EUDAMEDFDA UDI
- Model / Reference
- KF4060V EUDAMEDFDA UDI
- Description
- Cutaneous Electrode Pad FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719871189177 EUDAMEDFDA UDI
- Basic UDI-DI
- 471987118-ELECTRODE-H5 EUDAMED
- Direct Marketing DI
- 04719871189177 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
- Germany 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Everyway by Everyway Medical Instrument 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 | 471987118-ELECTRODE-H5 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Everyway Medical Instrument Co., Ltd.
- EUDAMED SRN
- TW-MF-000009887
- Authorised Representative
- Luana Med. B.V. NL-AR-000002750
Sources (2)
- EUDAMED c0cafdb8-1d9e-4369-a44e-0f1366a96eaa 61 fields · synced Jul 17, 2026
- FDA UDI cb0f9140-7868-42b3-9b68-96d8adeb159d 33 fields · synced May 30, 2026