Basic UDI-DI
Eu Mdr
Eu Md Class 2a
FLUOBEAM LS system
Code: ++B475CSFBLSXQ
Devices
3
Certificates
0
Notified Bodies
0
Auth. Representatives
0
Basic Information
- UDI-DI Code
- ++B475CSFBLSXQ
- Issuing Agency
- HIBCC
- Types
- None provided
- Regulation
- Eu Mdr
- Classification
- Eu Md Class 2a
- Last Updated
- October 21, 2024
Medical Purpose
FLUOBEAM LS including FLUOSOFT LS is indicated to facilitate the visualization of parathyroid glands by auto-fluorescence (natural fluorescence without ICG injection) during thyroid and parathyroid surgeries. FLUOBEAM LS including FLUOSOFT LS is indicated to visualize on a screen the flow, the distribution and/ or the accumulation of Indocyanine green (ICG) before, during and after surgery for the indications such as: • visualization of blood flow, vessels and tissue perfusion • visualization of lymphatic system, including lymph node and vessels • visualization of malignant tissues
Certificate Health
No certificates associated with this Basic UDI-DI.
Associated Devices
This Basic UDI-DI is associated with 3 devices.
| Name | Status |
|---|---|
| VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - HARDWARE ACCESSORIES | On the market |
| VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - HARDWARE ACCESSORIES | On the market |
| VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - HARDWARE ACCESSORIES | On the market |