Identity
- Trade Name
- iTouch Sure Lead EUDAMED
- Device Name
- Leads, Replacement, TENS EUDAMED
- Model / Reference
- L-ITS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05033435130894 EUDAMED
- Basic UDI-DI
- 5033435L00013ZL EUDAMED
- EMDN Code
- N018099 ENCEPHALIC AND PERIPHERAL NERVOUS SYSTEM DEVICES - ACCESSORIES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
iTouch Sure Lead by TensCare Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5033435L00013ZL | Class I | Active |
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Manufacturer
- Manufacturer
- TensCare Ltd
- EUDAMED SRN
- GB-MF-000004156
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 99b5ed5e-9a4a-44b7-ae96-42bca17e1d56 61 fields · synced Jul 17, 2026