Identity
- Trade Name
- CLIVEX SPLINT EUDAMED
- Device Name
- ALTOSPLINT Synthetic Orthopedic Splint EUDAMED
- Model / Reference
- CS312PFW EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809324047782 EUDAMED
- Basic UDI-DI
- 88093240410267U4 EUDAMED
- EMDN Code
- M03050202 SYNTHETIC CAST BANDAGES AND SPLINTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye 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
Clivex Splint by Altochem Co., Ltd — 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 | 88093240410267U4 | Class I | Active |
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Manufacturer
- Manufacturer
- Altochem Co., Ltd.
- EUDAMED SRN
- KR-MF-000024602
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 453819b3-ca67-4f95-ac79-fec98382e2dc 61 fields · synced Jul 8, 2026