Identity
- Trade Name
- Pinktens EUDAMED
- Device Name
- Pinktens EUDAMEDBluetens Classic 2 EUDAMED
- Model / Reference
- CL2P EUDAMEDCL2P_FR EUDAMEDCL2 EUDAMEDCL2P_UNI EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760071201603 EUDAMED03760071201597 EUDAMED03760071201948 EUDAMED
- Basic UDI-DI
- 3760071CL2PW9 EUDAMED3760071CL2A2 EUDAMED
- Direct Marketing DI
- 03760071201948 EUDAMED
- EMDN Code
- J020401 BLADDER INCONTINENCE NEUROSTIMULATORS EUDAMEDZ12062899 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
Pinktens 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 | 3760071CL2PW9 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Bluetens limited
- EUDAMED SRN
- CN-MF-000021806
- Authorised Representative
- S4M EUROPE FR-AR-000000180
Sources (4)
- EUDAMED 11967edc-e240-4e05-8e71-357d684c5c9f 61 fields · synced Jul 27, 2026
- EUDAMED 2a4fa41d-196d-4d7e-9f92-69e9cb69b78e 61 fields · synced Jun 18, 2026
- EUDAMED caa0365f-23f9-4e08-918e-4cce6a46994a 61 fields · synced Jul 9, 2026
- EUDAMED 451fc815-4f95-45b7-bd8f-5c4c64bf9b06 61 fields · synced Jul 27, 2026