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actiTENS
EUDAMEDClass IIa (EU MDR)
Ref SBM1AA007Model connected MD for transcutaneous electrical neurostimulation
by sublimed
Identity
- Trade Name
- actiTENS EUDAMED
- Device Name
- actiTENS kit / coffret VitaliTENS EUDAMED
- Model / Reference
- connected MD for transcutaneous electrical neurostimulation EUDAMEDSBM1AA007 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03770018808130 EUDAMED
- Basic UDI-DI
- 3770018808SBMKitCoffretZH EUDAMED
- EMDN Code
- Z120601 ELECTROTHERAPY EQUIPMENT (INCLUDED TENS) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- actiTENS kit : The actiTENS is a connected medical device for transcutaneous electrical neurostimulation intended to treat pain in adults and intended for persons over 18 years of age with unimpaired intellectual abilities coffret VitaliTENS : VitaliTENS is a medical device for transcutaneous electrical neurostimulation intended to treat chronic pain in adults suffering from knee osteoarthritis EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
actiTENS by Sublimed — 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 | 3770018808SBMKitCoffretZH | Class IIa | Active |
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Manufacturer
- Manufacturer
- sublimed
- EUDAMED SRN
- FR-PR-000015665
Sources (1)
- EUDAMED 0a322369-5490-42e5-867d-19a274753478 61 fields · synced May 22, 2026