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Transcutaneous Electrical Nerve Stimulator
EUDAMEDClass IIa (EU MDR)
Ref Z12062885
Identity
- Trade Name
- Transcutaneous Electrical Nerve Stimulator EUDAMED
- Device Name
- Transcutaneous Electrical Nerve Stimulators EUDAMED
- Model / Reference
- Z12062885 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06924607701815 EUDAMED
- Basic UDI-DI
- 69246077022497B EUDAMED
- EMDN Code
- Z12062885 NEUROMUSCULAR STIMULATION EQUIPMENT - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium 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
Transcutaneous Electrical Nerve Stimulator by Shenzhen Kentro Medical Electronics Co., 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 | 69246077022497B | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Kentro Medical Electronics CO., LTD.
- EUDAMED SRN
- CN-MF-000011247
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED 8d91dd78-918c-4c3a-8d06-bcbe822e1da3 61 fields · synced May 29, 2026