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actiTENS
EUDAMEDClass IIa (EU MDR)
Ref SBM1AA008Model connected MD for transcutaneous electrical neurostimulation Ref SBM1AC009Model Neurostimulation Electrodes
by sublimed
Identity
- Trade Name
- actiTENS EUDAMEDactiTENS - Sublimed EUDAMED
- Device Name
- actiTENS kit / coffret VitaliTENS EUDAMEDNeurostimulation Electrodes EUDAMED
- Model / Reference
- connected MD for transcutaneous electrical neurostimulation EUDAMEDSBM1AA008 EUDAMEDNeurostimulation Electrodes EUDAMEDSBM1AC009 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03770018808215 EUDAMED03770018808345 EUDAMED
- Basic UDI-DI
- 3770018808SBMKitCoffretZH EUDAMED00851913006StimWT EUDAMED
- EMDN Code
- Z120601 ELECTROTHERAPY EQUIPMENT (INCLUDED TENS) EUDAMEDN010201 TENS SYSTEM ELECTRODES EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMED
- Market of Registration
- France 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
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
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 (2)
- EUDAMED 16e0bfa1-fd23-4f3b-9b4e-494891f03fbe 61 fields · synced Jul 30, 2026
- EUDAMED 76741d6d-6fe6-4f75-b32c-bd73dc5508b3 61 fields · synced May 19, 2026