BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Kessel 3
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Flexicare EUDAMEDBritePro Solo Single-Use Fiber Optic Mini Handle and Blade Kessel 3 FDA UDI
- Generic Name
- Rigid intubation laryngoscope, single-use FDA UDI
- Device Name
- Single Use Laryngoscopes (Fibre Optic, Laryngoscope, Sterile) EUDAMED
- Model / Reference
- 040-02-0730U EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055788700074 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05055788700074 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
Single Use
Yes
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
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Rigid intubation laryngoscope, single-use
BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Kessel 3 by Flexicare Medical Limited — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
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 d05128a1-0b77-4248-9c4c-8aac4983d657 32 fields · synced Oct 8, 2026
- EUDAMED ea8a64ca-fbf0-4ece-ada4-7ead28385158 61 fields · synced Oct 8, 2026