← Back to catalogue
Optima View Video Laryngoscope Handle and LCD Display 3.75" for Single-Use Blad…
EUDAMEDFDA UDIClass I (EU MDR)
Ref 4000.310.50
Identity
- Trade Name
- Optima View Video Laryngoscope Handle and LCD Display 3.75" for Single-Use Blades EUDAMEDOptima View Video Laryngoscope for Single Use Blades FDA UDI
- Generic Name
- Video intubation laryngoscope handle/monitor FDA UDI
- Device Name
- Single Use Blade Video Laryngoscope EUDAMEDOptima View Video Laryngoscope Handle and LCD Display 3.75'' For Single Use Blades FDA UDI
- Model / Reference
- 4000.310.50 EUDAMEDFDA UDI
- Description
- Optima View Video Laryngoscope Handle and LCD Display 3.75'' For Single Use Blades FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055382859840 EUDAMEDFDA UDI
- Basic UDI-DI
- 50553828MDTF012K6 EUDAMED
- FDA Product Code
- CCW FDA UDI
- EMDN Code
- Z12021004 VIDEO LARYNGOSCOPES EUDAMED
- GMDN Term
- Video intubation laryngoscope handle/monitor FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.5540 FDA UDI
- Market of Registration
- Malta EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Optima View Video Laryngoscope Handle and LCD Display 3.75" for Single-Use Blad… by Timesco Healthcare Limited — Class I — MDR, FDA UDI — listed in EUDAMED…
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 50553828MDTF012K6 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Timesco Healthcare Limited
- EUDAMED SRN
- GB-MF-000021764
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED a288e5d9-a9fe-4723-baac-80c2d750ec8c 61 fields · synced Oct 7, 2026
- FDA UDI f871f61a-2318-42fb-8887-f229588b70b4 35 fields · synced May 30, 2026