Identity
- Trade Name
- Duo Sport 2 EUDAMED
- Device Name
- Bluetens Classic 2 EUDAMED
- Model / Reference
- CL2 EUDAMEDDS2AFS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760071201931 EUDAMED
- Basic UDI-DI
- 3760071CL2A2 EUDAMED
- Direct Marketing DI
- 03760071201931 EUDAMED
- EMDN Code
- Z12062899 NEUROMUSCULAR STIMULATION EQUIPMENT - OTHER 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
Duo Sport 2 by Bluetens limited — Class IIa — 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 | 3760071CL2A2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Bluetens limited
- EUDAMED SRN
- CN-MF-000021806
- Authorised Representative
- S4M EUROPE FR-AR-000000180
Sources (1)
- EUDAMED d9891f0d-1056-4ccc-90ea-78920545e343 61 fields · synced Jul 14, 2026