Identity
- Trade Name
- actiTENS EUDAMED
- Device Name
- actiTENS EUDAMEDactiTENS / VitaliTENS EUDAMED
- Model / Reference
- SBM1AA100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03770018808154 EUDAMED
- Basic UDI-DI
- B-03770018808154 EUDAMED3770018808SBMTENSAPPNU EUDAMED
- Direct Marketing DI
- 03770018808154 EUDAMED
- EMDN Code
- Z120601 ELECTROTHERAPY EQUIPMENT (INCLUDED TENS) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-03770018808154 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-03770018808154 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sublimed
- EUDAMED SRN
- FR-MF-000007546
Sources (2)
- EUDAMED 958c3f47-cf65-485e-869d-0538034bec20 61 fields · synced Aug 3, 2026
- EUDAMED 5c5c9681-14d1-4826-a1fb-0a95e99eb4b0 61 fields · synced May 19, 2026