Eu Mdr Eu Md Class 2a On The Market

VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - HARDWARE ACCESSORIES

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

Devices (same UDI-DI)
3
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
+B475CSFBLSIS0
Basic UDI-DI Code
++B475CSFBLSXQ
Reference
CS_FBLS_IS
Device Types
None provided
Regulation
Eu Mdr
Classification
Eu Md Class 2a
Status
On The Market

Additional Description

Integrated solution

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

CND Nomenclature Codes

Code Description
Z119080 VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - HARDWARE ACCESSORIES

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The Basic UDI-DI associated with this device has 3 devices in total. Below are some other devices sharing the same Basic UDI-DI.

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