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Breast Electrodes
EUDAMEDClass I (EU MDR)
Ref E-CM60130Model Adhesive Electrodes
by TensCare Ltd
Identity
- Trade Name
- Breast Electrodes EUDAMED
- Device Name
- Electrode, transcutaneous, electric nerve EUDAMED
- Model / Reference
- Adhesive Electrodes EUDAMEDE-CM60130 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05033435133130 EUDAMED
- Basic UDI-DI
- 5033435E00013WR EUDAMED
- EMDN Code
- N010201 TENS SYSTEM ELECTRODES EUDAMED
Classification
- Device Class
- Class I 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
Breast 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 | 5033435E00013WR | 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 99bd4cc6-e036-4799-9652-f930b4344721 61 fields · synced Jul 11, 2026