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actiTENS mini KIT
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref SBM7AA001_FRModel connected MD for transcutaneous electrical neurostimulation Ref SBM7AA100
by sublimed
Identity
- Trade Name
- actiTENS mini KIT EUDAMEDactiTENS mini EUDAMED
- Device Name
- actiTENS kit / coffret VitaliTENS EUDAMEDactiTENS / VitaliTENS EUDAMED
- Model / Reference
- connected MD for transcutaneous electrical neurostimulation EUDAMEDSBM7AA001_FR EUDAMEDSBM7AA100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03770018808246 EUDAMED03770018808260 EUDAMED
- Basic UDI-DI
- 3770018808SBMKitCoffretZH EUDAMED3770018808SBMTENSAPPNU EUDAMED
- Direct Marketing DI
- 03770018808260 EUDAMED
- EMDN Code
- Z120601 ELECTROTHERAPY EQUIPMENT (INCLUDED TENS) EUDAMED
Classification
- Device Class
- Class IIa 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 mini KIT by Sublimed — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K202159 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K252767 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 3770018808SBMKitCoffretZH | Class IIa | Active |
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Manufacturer
- Manufacturer
- sublimed
- EUDAMED SRN
- FR-PR-000015665
Sources (3)
- EUDAMED 3134a47d-e497-4271-8687-629479226577 61 fields · synced Jul 18, 2026
- EUDAMED 41c2f523-6f4b-4444-8bfc-2cb2f9b0317b 61 fields · synced May 18, 2026
- FDA 510(k) K202159 1 fields · synced May 18, 2026