Alivia
by TensCare Ltd
Ref K-ALIVIA
K-ALIVIA is a medical device (EU MDR Class IIa; EMDN category pelvic floor rehabilitation devices) made by TensCare Ltd, registered in EUDAMED on 2 Sep 2024 (Basic UDI-DI 5033435K00138DSU), active as of 22 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number5033435K00138DSU | Date2 Sep 2024 | StatusActive |
Official records
- EUDAMED public site 5033435K00138DSU
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / reference
- K-ALIVIA
- Primary DI / UDI-DI
- 05033435136278, 05033435135967
- Basic UDI-DI
- 5033435K00138DSU, 5033435K00138ZU
- EMDN code
- U070399 Pelvic floor rehabilitation devices - other
- Device class
- Class IIa
- System or procedure pack
- Procedure pack
- EU registration type
- Standard deviceSystem or procedure pack
- EU market of registration
- Netherlands
- 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.
Manufacturer details
- EUDAMED SRN
- GB-MF-000004156
- Authorised representative
- Advena Limited MT-AR-000000234
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