333/OPT-001 Optimus Console Support With Arm & Column
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- 333/OPT-001 Optimus Console Support With Arm & Column EUDAMEDKENEX FDA UDI
- Generic Name
- Medical monitor/light mount FDA UDI
- Device Name
- Pendant Systems for monitor and controls EUDAMEDOptimus Console Support With Arm & Column FDA UDI
- Model / Reference
- 333/OPT-001 EUDAMEDFDA UDI
- Description
- Optimus Console Support With Arm & Column FDA UDI
Identifiers
- Catalog Number
- 333/OPT-001 FDA UDI
- Primary DI / UDI-DI
- 05055449411530 EUDAMEDFDA UDI
- Basic UDI-DI
- 50554494PDOWU EUDAMED
- Direct Marketing DI
- 05055449411530 EUDAMED
- FDA Product Code
- FSY FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Medical monitor/light mount FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4580 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Device sterilization/disinfection container, reusable
333/OPT-001 Optimus Console Support With Arm & Column by Kenex (electro-Medical) Limited — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 50554494PDOWU | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Kenex (Electro-Medical) Limited
- EUDAMED SRN
- GB-MF-000009022
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 6d8e39e0-27df-4186-b657-f7f16b5ff13c 61 fields · synced Jul 15, 2026
- FDA UDI e91d6db3-ece5-4f65-bd8b-a3a9f2f3be45 34 fields · synced May 29, 2026