Identity
- Trade Name
- VitaliTENS EUDAMED
- Device Name
- VitaliTENS EUDAMEDactiTENS / VitaliTENS EUDAMED
- Model / Reference
- 8703703 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03770018808055 EUDAMED
- Basic UDI-DI
- B-03770018808055 EUDAMED3770018808SBMTENSAPPNU EUDAMED
- Direct Marketing DI
- 03770018808055 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
VitaliTENS 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-03770018808055 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-03770018808055 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sublimed
- EUDAMED SRN
- FR-MF-000007546
Sources (2)
- EUDAMED a758d3b2-5c20-495a-93d2-c09df2498996 61 fields · synced Jul 19, 2026
- EUDAMED a7cbc463-0b14-47fa-baac-aba8e9ffd268 61 fields · synced May 19, 2026