Identity
- Trade Name
- Sure PRO EUDAMED
- Device Name
- Sure PRO EUDAMED
- Model / Reference
- K-SP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05033435130825 EUDAMED
- Basic UDI-DI
- 5033435K00072ZP EUDAMED
- EMDN Code
- U070399 PELVIC FLOOR REHABILITATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Sure PRO 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. Sure PRO may help to relieve symptoms of chronic pelvic pain. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Sure PRO 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 | 5033435K00072ZP | Class IIa | Active |
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Manufacturer
- Manufacturer
- TensCare Ltd
- EUDAMED SRN
- UK-PR-000039358
Sources (1)
- EUDAMED 337219d2-0c5f-43b5-be12-ed1a94e55eb9 61 fields · synced Jun 18, 2026