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Operion 355 Ultra Dual View (slim)
EUDAMEDClass I (EU MDR)
Ref OP-35U.4-SModel Wall System MonitorRef OP-35U.4
Identity
- Trade Name
- OPERION 355 ULTRA DUAL VIEW (SLIM) EUDAMEDOPERION 355 ULTRA DUAL VIEW EUDAMED
- Device Name
- WS5UDV.1 EUDAMED
- Model / Reference
- Wall System Monitor EUDAMEDOP-35U.4-S EUDAMEDOP-35U.4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04061631011199 EUDAMED04061631010659 EUDAMED
- Basic UDI-DI
- 406163100000WS5UDV1WX EUDAMED
- Direct Marketing DI
- 04061631011199 EUDAMED04061631010659 EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER 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
Category: Device sterilization/disinfection container, reusable
Operion 355 Ultra Dual View (slim) by Rein medical GmbH — Class I — 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 | 406163100000WS5UDV1WX | Class I | Active |
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Manufacturer
- Manufacturer
- Rein medical GmbH
- EUDAMED SRN
- DE-MF-000018721
Sources (2)
- EUDAMED fc8effac-daab-402d-8e6f-ae25811167b8 61 fields · synced Jul 27, 2026
- EUDAMED d95a4542-a334-4280-bc5f-46ce5c2c0dc1 61 fields · synced May 19, 2026