Identity
- Trade Name
- SELEFA Tongue depressor EUDAMED
- Device Name
- Tongue Depressor, non-sterile EUDAMED
- Model / Reference
- 140680 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438129352702 EUDAMED
- Basic UDI-DI
- 6438129B0022H4 EUDAMED
- EMDN Code
- V9001 TONGUE DEPRESSORS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden 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
SELEFA Tongue depressor by OneMed Group 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 | 6438129B0022H4 | Class I | Active |
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Manufacturer
- Manufacturer
- OneMed Group Oy
- EUDAMED SRN
- FI-MF-000000642
Sources (1)
- EUDAMED 419892f0-eed5-4118-a19d-4c0f4d0ebd71 61 fields · synced Jun 19, 2026