Identity
- Trade Name
- Alivia EUDAMED
- Device Name
- Alivia EUDAMED
- Model / Reference
- K-ALIVIA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05033435135967 EUDAMED
- Basic UDI-DI
- 5033435K00138ZU EUDAMED
- EMDN Code
- U070399 PELVIC FLOOR REHABILITATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Alivia 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. Alivia may also help to relieve the pain of secondary menstrual pain due to conditions such as endometriosis, fibroids or pelvic inflammatory disease. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Alivia 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 | 5033435K00138ZU | Class IIa | Active |
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Manufacturer
- Manufacturer
- TensCare Ltd
- EUDAMED SRN
- UK-PR-000039358
Sources (1)
- EUDAMED f7ff9e96-652c-4f0b-9556-3721178600ca 61 fields · synced Jul 9, 2026