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FLUOBEAM LX Red system
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref CS_FBLXR_PCRef FBLXRRef CS_FBLXR_ISRef CS_FBLXR_DURef CS_FBLXRRef FBLX
Identity
- Trade Name
- FLUOBEAM LX Red EUDAMEDFLUOBEAM LX EUDAMED
- Device Name
- FLUOBEAM LX Red system EUDAMEDFLUOBEAM LX Red EUDAMEDFLUOBEAM LX/LM EUDAMED
- Model / Reference
- CS_FBLXR_PC EUDAMEDFBLXR EUDAMEDCS_FBLXR_IS EUDAMEDCS_FBLXR_DU EUDAMEDCS_FBLXR EUDAMEDFBLX EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B475CSFBLXRPCS/CL0 EUDAMED+B475FBLXR0 EUDAMED+B475CSFBLXRIS/CL0 EUDAMED+B475CSFBLXRDU/CL0 EUDAMED+B475CSFBLXRS/CL0 EUDAMED+B475FBLX0 EUDAMED
- Basic UDI-DI
- ++B475CSFBLXRX9 EUDAMED++B475FBLXR36 EUDAMED++B475FB9E EUDAMED
- Direct Marketing DI
- +B475FBLXR0 EUDAMED+B475FBLX0 EUDAMED
- EMDN Code
- Z119080 VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
- Medical Purpose
- FLUOBEAM LX Red including FLUOSOFT LX Red is indicated to facilitate the visualization of parathyroid glands by auto-fluorescence (natural fluorescence without ICG injection) during thyroid and parathyroid surgeries. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
FLUOBEAM LX Red system by Fluoptics Sas — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K230898 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | ++B475CSFBLXRX9 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Fluoptics Sas
- EUDAMED SRN
- FR-PR-000002882
Sources (7)
- EUDAMED b2f0c80e-69e6-4697-a440-1a2f24817b69 61 fields · synced Aug 2, 2026
- EUDAMED 315dcf0e-5076-40b0-ad50-d35780d8f9ca 61 fields · synced May 17, 2026
- EUDAMED a7117240-aaeb-4f84-932a-5fd9f5a23cb2 61 fields · synced May 17, 2026
- EUDAMED 11682573-bff7-43f2-9dc4-01eeae447d42 61 fields · synced May 18, 2026
- EUDAMED d60fd879-6de3-40e8-8715-243086dbd5b9 61 fields · synced May 18, 2026
- EUDAMED 63434b59-a1ed-49ce-9dc4-d2e4f91d6208 61 fields · synced May 18, 2026
- FDA 510(k) K230898 1 fields · synced May 18, 2026