Identity
- Trade Name
- SMART SEDYE EUDAMED
- Device Name
- SEDYELER EUDAMED
- Model / Reference
- SST01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08698915160579 EUDAMED
- Basic UDI-DI
- 869891516TRANSAMJK EUDAMED
- EMDN Code
- V080202 MANUAL MEDICAL CHAIRS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Smart Sedye by Mone Medi̇kal Ti̇caret Ve Sanayi̇ Anoni̇m Şi̇rketi̇ — 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 | 869891516TRANSAMJK | Class I | Active |
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Manufacturer
- Manufacturer
- Mone Medi̇kal Ti̇caret Ve Sanayi̇ Anoni̇m Şi̇rketi̇
- EUDAMED SRN
- TR-MF-000024355
Sources (1)
- EUDAMED b1fd3c71-6272-4a1d-9f85-7e710fe65bf6 61 fields · synced Oct 6, 2026