Identity
- Trade Name
- OpenOR S-Tech System EUDAMED
- Device Name
- OpenOR System EUDAMED
- Model / Reference
- 200040005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438435400050 EUDAMED
- Basic UDI-DI
- 6438435SY0001UH EUDAMED
- EMDN Code
- Y241299 AMBIENT CONTROL SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Medical Purpose
- The OpenOR System is intended for an integrated operating room control system for non-medical and class I medical devices. OpenOR System is used for transmitting information and to control non-medical and medical devices in an operating room. The OpenOR System does not have medical purpose. The OpenOR System is not intended for diagnosis and to control MDR Class Is, Im, IIa, IIb and III medical devices. The OpenOR System must be used in an operating room environment by trained healthcare professionals only. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
OpenOR S-Tech System by Merivaara Corporation — 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 | 6438435SY0001UH | Class I | Active |
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Manufacturer
- Manufacturer
- Merivaara Corporation
- EUDAMED SRN
- FI-PR-000003558
Sources (1)
- EUDAMED 19967d6c-7f8a-4e59-998b-f8f8a1de2682 61 fields · synced Jul 25, 2026