Identity
- Trade Name
- Elise 2 EUDAMED
- Device Name
- Elise 2 EUDAMED
- Model / Reference
- K-EL2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05033435134274 EUDAMED
- Basic UDI-DI
- 5033435K00106ZF EUDAMED
- EMDN Code
- U070399 PELVIC FLOOR REHABILITATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
Elise 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 | 5033435K00106ZF | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- TensCare Ltd
- EUDAMED SRN
- GB-MF-000004156
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 5e36ad8d-2634-4fb9-8990-c00d8056ce57 61 fields · synced Jun 19, 2026