Identity
- Device Name
- iTouch Sure 2 EUDAMED
- Model / Reference
- K-ITS-GO EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05033435132362 EUDAMED
- Basic UDI-DI
- 5033435K00025ZE EUDAMED
- EMDN Code
- U070399 PELVIC FLOOR REHABILITATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- iTouch sure is a medical device designed to be used in the home healthcare environment to treat symptoms of urinary and/or faecal incontinence and is suitable for use by all who can control the device and understand the instructions. Do not use the device for any purpose other than this intended use. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
iTouch Sure 2 by TensCare Ltd — Class IIa — 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 | 5033435K00025ZE | Class IIa | Active |
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Manufacturer
- Manufacturer
- TensCare Ltd
- EUDAMED SRN
- UK-PR-000039358
Sources (1)
- EUDAMED aabb344d-e615-4793-8684-c10794aad024 61 fields · synced Jul 8, 2026