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New mamaTENS Electrodes
EUDAMEDClass I (EU MDR)
Ref E-CM50100MT-NEW
by TensCare Ltd
Identity
- Trade Name
- New mamaTENS Electrodes EUDAMED
- Device Name
- Perfect MamaTENS Electrodes EUDAMED
- Model / Reference
- E-CM50100MT-NEW EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05033435130092 EUDAMED
- Basic UDI-DI
- 5033435E00010WK EUDAMED
- EMDN Code
- N010201 TENS SYSTEM ELECTRODES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark 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
New mamaTENS Electrodes by TensCare Ltd — Class I — 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 | 5033435E00010WK | Class I | Active |
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Manufacturer
- Manufacturer
- TensCare Ltd
- EUDAMED SRN
- GB-MF-000004156
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 6d5e07f6-e2c7-4e57-b0af-9970320cd9a9 61 fields · synced Jun 18, 2026