Identity
- Trade Name
- Infant Incubator EUDAMED
- Device Name
- Infant Incubator EUDAMED
- Model / Reference
- OKM 801 EUDAMEDOKM 801 333 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08680992311524 EUDAMED
- Basic UDI-DI
- B-08680992311524 EUDAMED
- EMDN Code
- Z1208040302 MOBILE NEONATAL INCUBATORS EUDAMED
Classification
- Device Class
- Class IIb 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Infant Incubator 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-08680992311524 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Okuman Medikal Sistemler Anonim Sirketi
- EUDAMED SRN
- TR-MF-000015167
Sources (1)
- EUDAMED e929dbfc-c2e2-43a7-8e17-692107e5c2b4 61 fields · synced Jun 19, 2026