Identity
- Trade Name
- Duo Care EUDAMED
- Device Name
- Bluetens Classic 2 EUDAMED
- Model / Reference
- CL2 EUDAMEDCL2M_AFS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760071201610 EUDAMED
- Basic UDI-DI
- 3760071CL2A2 EUDAMED
- Direct Marketing DI
- 03760071201610 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 Care 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 144dbc83-16d4-4c72-b44f-9020793a0ae1 61 fields · synced Jul 9, 2026