Singapore HSA registration DE0502045
Leica Microsystems GLOW800
Singapore·CLASS B·Leica Microsystems (Schweiz) AG·Registered August 20, 2018Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Neurology
Registration information
- Registration Number
- DE0502045
- Registration Date
- August 20, 2018
- Change Notification Approval Date
- December 17, 2024
- Retention Due Date
- August 19, 2025
Product description
The GLOW800 is used in viewing fluorescence of fluorophores with an excitation peak between ~750 nm and ~800 nm and the resulting fluorescence emission observation in a spectral band above ~800 nm. The GLOW800 is a Leica surgical microscope accessory used in viewing intra-operative blood flow in the cerebral vascular area as well as blood flow during plastic and reconstructive surgery.
Product Owner
- Short Name
- Leica Microsystems (Schweiz) AG
- Address
- Max Schmidheinly-Strasse 201, SWITZERLAND
Registrant
- Address
- 15 TUKANG INNOVATION DRIVE, SINGAPORE 618299
Importer
- Address
- 15 TUKANG INNOVATION DRIVE, SINGAPORE 618299 15 TUKANG INNOVATION DRIVE, SINGAPORE 618299
Model information
- Model Name(s)
- Leica M530 OHX GLOW800 ARveo 8 GLOW800 ARveo 8
- Model Identifier(s)
- 10448737 10448962 10449063 10449156 10449157
About this record
Access comprehensive regulatory information for Leica Microsystems GLOW800 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0502045 and owned by Leica Microsystems (Schweiz) AG. The device was registered on August 20, 2018.
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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