Identity
- Trade Name
- ComfoLeads, CSNP EUDAMED
- Device Name
- ComfoLeads EUDAMED
- Model / Reference
- CSNP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06430067180188 EUDAMED
- Basic UDI-DI
- 6430067180006V2 EUDAMED
- EMDN Code
- Z12101185 PERIPHERAL OR CENTRAL NEURO STIMULATION AND ASSESSMENT INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland 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
ComfoLeads, CSNP by Sooma Oy — 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 | 6430067180006V2 | Class I | Active |
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Manufacturer
- Manufacturer
- Sooma Oy
- EUDAMED SRN
- FI-MF-000004844
Sources (1)
- EUDAMED f0af2319-157b-4a88-9c81-11e6c17af222 61 fields · synced Aug 1, 2026