Identity
- Trade Name
- Central Monitoring System EUDAMED
- Device Name
- Central Monitoring System EUDAMED
- Model / Reference
- OKM 8800 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08680052456004 EUDAMED
- Basic UDI-DI
- B-08680052456004 EUDAMED
- EMDN Code
- Z1203020202 TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Central Monitoring System by Okuman Medikal Sistemler Anonim Sirketi — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08680052456004 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Okuman Medikal Sistemler Anonim Sirketi
- EUDAMED SRN
- TR-MF-000015167
Sources (1)
- EUDAMED 3c0a0fae-2be7-41e5-885c-700bb80bba42 61 fields · synced Jun 19, 2026