Identity
- Trade Name
- Bluetens Classic 2 EUDAMED
- Device Name
- Bluetens Classic 2 EUDAMED
- Model / Reference
- CL2 EUDAMEDCL2FR EUDAMEDCL2UNI EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760071201924 EUDAMED03760071201689 EUDAMED03760071201665 EUDAMED
- Basic UDI-DI
- 3760071CL2A2 EUDAMED
- Direct Marketing DI
- 03760071201924 EUDAMED03760071201689 EUDAMED03760071201665 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
Bluetens Classic 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 (3)
- EUDAMED 724815df-2180-4361-90e8-12b522ce12dd 61 fields · synced Jul 20, 2026
- EUDAMED 33e98b6e-d4fb-4b8b-ba18-3b29631050cd 61 fields · synced May 17, 2026
- EUDAMED 9bf38241-2e89-4961-b008-c79dde88eb1c 61 fields · synced May 17, 2026