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Key for Smile EXTRA
EUDAMEDClass I (EU MDR)
Ref IT0414Model Distractor Keys
by Titamed
Identity
- Trade Name
- Key for Smile EXTRA EUDAMED
- Model / Reference
- Distractor Keys EUDAMEDIT0414 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05404024307896 EUDAMED
- Basic UDI-DI
- 54040243BASIC0075H EUDAMED
- EMDN Code
- L098002 ORTHOPAEDIC INSTRUMENTS KEYS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
Key for Smile EXTRA by Titamed — 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 | 54040243BASIC0075H | Class I | Active |
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Manufacturer
- Manufacturer
- Titamed
- EUDAMED SRN
- BE-MF-000000110
Sources (1)
- EUDAMED 9800b6fe-7d4c-4c71-997a-299018a6eaa1 61 fields · synced Jun 20, 2026