Identity
- Trade Name
- Flexicare EUDAMEDBritePro Omni FDA UDI
- Generic Name
- Rigid intubation laryngoscope, single-use FDA UDI
- Device Name
- Single Use Laryngoscopes (Fibre Optic, Laryngoscope, Sterile) EUDAMEDBritePro Omni Single-Use Laryngoscope Handle With Miller Ultra 3 FDA UDI
- Model / Reference
- 040-04-2030U EUDAMEDFDA UDI
- Description
- BritePro Omni Single-Use Laryngoscope Handle With Miller Ultra 3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055931100362 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05055931100362 EUDAMED
- FDA Product Code
- CCW FDA UDI
- EMDN Code
- R9002 LARYNGOSCOPE BLADES, SINGLE-USE EUDAMED
- GMDN Term
- Rigid intubation laryngoscope, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.5540 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Rigid intubation laryngoscope, single-use
BritePro Omni by Flexicare Medical Limited — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Flexicare Medical Limited
Sources (2)
- FDA UDI f90db491-d012-4634-968c-ab6860d383f5 33 fields · synced Oct 9, 2026
- EUDAMED b61ae845-b371-4f28-ab95-f23cb3a6f398 61 fields · synced Oct 9, 2026