Identity
- Trade Name
- LogoTENS EUDAMED
- Device Name
- Unifit EUDAMED
- Model / Reference
- K-LOGO EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05033435139682 EUDAMED05033435139699 EUDAMED
- Basic UDI-DI
- 5033435K00176DTA EUDAMED5033435K0017627 EUDAMED
- Direct Marketing DI
- 05033435139682 EUDAMED
- EMDN Code
- Z12062801 MUSCLE REINFORCEMENT STIMULATORS FOR INNERVATED MUSCLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMED
- Medical Purpose
- to be used in the home healthcare environment to improve muscle tone and bulk, as well as provide symptomatic relief and management of acute or chronic localised pain and muscle pain. It is suitable for use by all who can control the device and understand the instructions. 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
LogoTENS 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 | 5033435K00176DTA | Class IIa | Active |
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Manufacturer
- Manufacturer
- TensCare Ltd
- EUDAMED SRN
- GB-MF-000004156
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED bf53d831-9825-4e53-b790-11440d7f4a5a 61 fields · synced Jul 25, 2026
- EUDAMED 3ecd4056-73f7-4130-8eeb-0abebd5b4028 61 fields · synced May 17, 2026