Identity
- Trade Name
- BritePro FDA UDI
- Generic Name
- Laryngoscope handle, reusable FDA UDI
- Device Name
- Reusable Laryngoscopes EUDAMEDBritePro Max LED Fiber Optic Reusable Laryngoscope Replacement Light Source for Standard Handle FDA UDI
- Model / Reference
- 041-813U EUDAMEDFDA UDI
- Description
- BritePro Max LED Fiber Optic Reusable Laryngoscope Replacement Light Source for Standard Handle FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055788771227 EUDAMEDFDA UDI
- Basic UDI-DI
- 5055788700120D04K8 EUDAMED
- FDA Product Code
- CCW FDA UDI
- EMDN Code
- Z12021003 LARYNGOSCOPES EUDAMED
- GMDN Term
- Laryngoscope handle, reusable 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Laryngoscope handle, reusable
BritePro by Flexicare Medical Limited — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | 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 673d750a-175a-43b5-a7cb-d3baaa4ea604 33 fields · synced Oct 5, 2026
- EUDAMED 3ac45cf9-2312-478e-abb3-e3ec730e61bd 61 fields · synced Oct 5, 2026