Identity
- Trade Name
- actiTENS belt/ bra accessory EUDAMED
- Device Name
- actiTENS Textile accessory EUDAMED
- Model / Reference
- SBM1AG400 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03770018808086 EUDAMED
- Basic UDI-DI
- 3770018808ATactiTENS1ZW EUDAMED
- Direct Marketing DI
- 03770018808086 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 belt/ bra accessory 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 9930f330-5ca2-4b9b-99b7-e71eadbb99d4 61 fields · synced Jun 19, 2026