Identity
- Trade Name
- actiTENS armband (XL size) EUDAMED
- Device Name
- actiTENS Textile accessory EUDAMED
- Model / Reference
- SBM1AG302 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03770018808116 EUDAMED
- Basic UDI-DI
- 3770018808ATactiTENS1ZW EUDAMED
- Direct Marketing DI
- 03770018808116 EUDAMED
- EMDN Code
- Z120601 ELECTROTHERAPY EQUIPMENT (INCLUDED TENS) EUDAMED
Classification
- Device Class
- Class I 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 armband (XL size) by Sublimed — Class I — 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 | 3770018808ATactiTENS1ZW | Class I | Active |
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Manufacturer
- Manufacturer
- Sublimed
- EUDAMED SRN
- FR-MF-000007546
Sources (1)
- EUDAMED 237ac5d6-96f5-47fb-a2aa-2fd3696abeaa 61 fields · synced Jul 29, 2026