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Oks 2000
EUDAMEDClass IIb (EU MDR)
Ref OKS 2000 - komplett SystemModel OKS 2000Ref 0302 000x
Identity
- Trade Name
- OKS 2000 EUDAMED
- Device Name
- OKS 2000 - Gesamtsystem EUDAMEDOKS 2000 EUDAMED
- Model / Reference
- OKS 2000 EUDAMEDOKS 2000 - komplett System EUDAMED0302 000x EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04262357040078 EUDAMED04262357040030 EUDAMED
- Basic UDI-DI
- 426235704OKS2000-SystemXT EUDAMED426235704OKS20009B EUDAMED
- Direct Marketing DI
- 04262357040030 EUDAMED
- EMDN Code
- Z110310 MULTIFUNCTIONAL SYSTEMS FOR TRADITIONAL RADIOLOGY EUDAMEDZ11030503 PATIENT TABLES FOR RADIOLOGICAL EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass I EUDAMED
- Market of Registration
- Germany EUDAMED
- Medical Purpose
- The System OKS 2000 is designed as a universal X-ray workstation and can be operated in private practices and in hospitals. The System OKS 2000 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
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
Category: Stationary basic diagnostic x-ray system, analogue
Oks 2000 by Integral Medical GmbH — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 426235704OKS2000-SystemXT | Class IIb | Active |
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Manufacturer
- Manufacturer
- Integral Medical GmbH
- EUDAMED SRN
- DE-PR-000028463
Sources (2)
- EUDAMED cf9403f7-444d-4ecc-aef7-c91440635a2b 61 fields · synced Jul 19, 2026
- EUDAMED cc146239-cc06-471a-a6d8-e259f5d50441 61 fields · synced May 17, 2026