Identity
- Trade Name
- OKS 3000 EUDAMED
- Device Name
- OKS 3000 - Gesamtsystem EUDAMED
- Model / Reference
- OKS 3000 EUDAMED0203000x EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04262357040085 EUDAMED
- Basic UDI-DI
- 426235704OKS3000-SystemYS EUDAMED
- EMDN Code
- Z110310 MULTIFUNCTIONAL SYSTEMS FOR TRADITIONAL RADIOLOGY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Medical Purpose
- The System OKS 3000 is designed as a universal X-ray workstation and can be operated in private practices and in hospitals. The System OKS 3000 is intended for diagnostic imaging in human medicine. It is used to position a patient in X-ray diagnostics and is intended exclusively for shooting the skull, thorax, pelvis, skeleton and extremities on the lying or sitting and in conjunction with the OKS W100 also on standing patients. The operator is responsible for compliance with the regulations that apply to the installation and operation of an X-ray system. It may only be operated and maintained by persons with the necessary professional qualifications. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Oks 3000 by Integral Medical GmbH — Class IIb — 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 | 426235704OKS3000-SystemYS | Class IIb | Active |
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Manufacturer
- Manufacturer
- Integral Medical GmbH
- EUDAMED SRN
- DE-PR-000028463
Sources (1)
- EUDAMED 43cbec4f-386b-44c6-9f36-5cfc486967d2 61 fields · synced Jun 18, 2026