Identity
- Trade Name
- ComfoTrode, B EUDAMED
- Device Name
- ComfoTrode, B EUDAMED
- Model / Reference
- CE25B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06430067180157 EUDAMED
- Basic UDI-DI
- 6430067180004UW 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
ComfoTrode, B 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 | 6430067180004UW | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sooma Oy
- EUDAMED SRN
- FI-MF-000004844
Sources (1)
- EUDAMED 640b4167-d071-4532-8a9c-339c5f86d11c 61 fields · synced Jul 10, 2026