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Neck Electrode
EUDAMEDFDA UDIClass I (EU MDR)
Ref E-TRALNEModel Aliment Electrode
by TensCare Ltd
Identity
- Trade Name
- Neck Electrode EUDAMEDTensCare FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
- Device Name
- Aliment Electrode EUDAMEDThe Neck Electrode is a reusable electrode, with an intended use for the desired success of any stimulation (TENS or EMS). They are intended for a single user. FDA UDI
- Model / Reference
- Aliment Electrode EUDAMEDE-TRALNE EUDAMEDNeck Electrode FDA UDI
- Description
- The Neck Electrode is a reusable electrode, with an intended use for the desired success of any stimulation (TENS or EMS). They are intended for a single user. FDA UDI
Identifiers
- Catalog Number
- E-TRALNE FDA UDI
- Primary DI / UDI-DI
- 05033435139729 EUDAMEDFDA UDI
- Basic UDI-DI
- 5033435E00070X5 EUDAMED
- 510(k) Number
- K210448 FDA UDI
- FDA Product Code
- GXY FDA UDI
- EMDN Code
- N010201 TENS SYSTEM ELECTRODES EUDAMED
- GMDN Term
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Market of Registration
- Greece 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
No
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Neck Electrode by TensCare 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 | 5033435E00070X5 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- TensCare Ltd
- EUDAMED SRN
- GB-MF-000004156
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 759f5571-008d-4ad5-aab8-48c598790ae3 61 fields · synced Jun 19, 2026
- FDA UDI 8b8bdb01-830a-45de-a003-55fa6abd37de 35 fields · synced May 25, 2026