Identity
- Trade Name
- OKS W100 EUDAMED
- Device Name
- OKS 1000 EUDAMED
- Model / Reference
- 0301 000x EUDAMED0201 0003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04262357040016 EUDAMED
- Basic UDI-DI
- 426235704OKSH7 EUDAMED
- Direct Marketing DI
- 04262357040016 EUDAMED
- EMDN Code
- Z11030501 COLUMN STANDS FOR RADIOLOGICAL EQUIPMENT EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Oks W100 by Integral Medical GmbH — 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 | 426235704OKSH7 | Class I | Active |
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Manufacturer
- Manufacturer
- Integral Medical GmbH
- EUDAMED SRN
- DE-MF-000006198
Sources (1)
- EUDAMED 043e1889-4cf7-459e-bccc-45c38daa3f44 61 fields · synced Jun 18, 2026