Identity
- Trade Name
- Sooma DUO EUDAMED
- Device Name
- Sooma DUO EUDAMED
- Model / Reference
- DCS6 EUDAMEDSooma Duo EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06430067180270 EUDAMED
- Basic UDI-DI
- 6430067180007V4 EUDAMED
- Direct Marketing DI
- 06430067180270 EUDAMED
- EMDN Code
- Z12101106 NEUROLOGICAL STIMULATORS EUDAMED
Classification
- Device Class
- Class IIa 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
Category: Point aesthesiometer
Sooma DUO by Sooma Oy — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 6430067180007V4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sooma Oy
- EUDAMED SRN
- FI-MF-000004844
Sources (1)
- EUDAMED f5ca00f2-4d6e-491f-b83a-903f836e45ee 61 fields · synced Jul 11, 2026