Singapore HSA registration DE0509075
FLUOPTICS FLUOBEAM imaging system
Singapore·CLASS B·FLUOPTICS SAS·Registered March 18, 2024Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Radiology / Imaging
Registration information
- Registration Number
- DE0509075
- Registration Date
- March 18, 2024
- Retention Due Date
- March 17, 2026
Product description
FLUOBEAM LX/LM is an imaging system designed to observe fluorescent images. Without indocyanine green (ICG) injection: FLUOBEAM LX/LM is indicated to facilitate the visualization of parathyroid glands by autofluorescence (natural fluorescence without ICG injection) during thyroid and parathyroid surgeries. With indocyanine green (ICG) injection: FLUOBEAM LX/LM 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, • visualization of lymph flow, • visualization and identification of bile ducts during hepatobiliary surgery, • visualization and detection of primary liver tumors and/or hepatic metastases.
Product Owner
- Name
- FLUOPTICS SAS
- Short Name
- FLUOPTICS SAS
- Address
- 44 rue des Berges, 38000 Grenoble, FRANCE
Registrant
- Address
- 20 BENDEMEER ROAD, #06-01/02, SINGAPORE 339914
Importer
- Address
- 20 BENDEMEER ROAD, CyberHub Building, #06-02, SINGAPORE 339914 20 BENDEMEER ROAD, #06-01/02, SINGAPORE 339914
Model information
- Model Name(s)
- FLUOBEAM LM FLUOBEAM LX Medical Panel PC Medical Panel PC
- Model Identifier(s)
- FBLM FBLX MLC8-23 WMP-24C
About this record
Access comprehensive regulatory information for FLUOPTICS FLUOBEAM imaging system in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509075 and owned by FLUOPTICS SAS. The device was registered on March 18, 2024.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
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