Identity
- Trade Name
- SMART DİYALİZ KOLTUĞU 4M EUDAMED
- Device Name
- TIBBİ KOLTUKLAR EUDAMED
- Model / Reference
- SDA02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08698915160609 EUDAMED
- Basic UDI-DI
- 869891516MONECHAIRCM EUDAMED
- EMDN Code
- V08020101 GENERIC USE ELECTRIC 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 Di̇yali̇z Koltuğu 4m 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 | 869891516MONECHAIRCM | Class I | Active |
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Manufacturer
- Manufacturer
- Mone Medi̇kal Ti̇caret Ve Sanayi̇ Anoni̇m Şi̇rketi̇
- EUDAMED SRN
- TR-MF-000024355
Sources (1)
- EUDAMED b25f836a-2b05-487e-a3fd-d615518569d0 61 fields · synced Oct 7, 2026