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Quantel Medical ABSolu - HSA Registration DE0508127

Access comprehensive regulatory information for Quantel Medical ABSolu in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508127 and owned by Quantel Medical. The device was registered on May 25, 2023.

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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CLASS B
DE0508127
Quantel Medical ABSolu
HSA Registration Number: DE0508127
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Product Description

The ABSolu Ophthalmic Ultrasound System is indicated to be used on children, young adults, adults, and elderly people, with the exceptions listed in the contraindications. The ABSolu is a high definition multifunction ophthalmic ultrasound system used for: • Axial Length measurement of the eye by ultrasonic means; • Implanted IOL power calculation, using the axial length measurement; • Visualization of the interior of the eye and the orbit by A and B scans. • ABSOLU S only: Advanced diagnostic - Standardized echography provides detailed information about the internal reflectivity of tissues and allows optimal tissues differentiation, localization and measurement of structures in the eye and orbit.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Ophthalmology
Registration Information
Registration Number
DE0508127
Registration Date
May 25, 2023
Change Notification Approval Date
March 18, 2024
Retention Due Date
May 24, 2025
Product Owner
Short Name
Quantel Medical
Address
1, rue du bois joli, CS 40015, 63808 Cournon d’Auvergne Cedex, FRANCE
Registrant
Address
5 JALAN KILANG BARAT, PETRO CENTRE, #09-05, SINGAPORE 159349
Importer
Address
5 JALAN KILANG BARAT, PETRO CENTRE, #09-00, SINGAPORE 159349
Model Information
Model Name(s)
ABSolu A/B Mode including:15Mhz B Probe (B1), Biometry Probe ABSolu B Mode including:15Mhz B Probe (B1) ABSolu A/B Mode including:15Mhz B Probe (B1), Biometry Probe with Laser Aiming Beam (ProBeam?) ABSolu A/B Mode including:20Mhz-5A Annular Probe (B20-5A), Biometry Probe ABSolu A/B Mode including:20Mhz-5A Annular Probe (B20-5A), Biometry Probe with Laser Aiming Beam (ProBeam?) ABSolu B Mode including:20Mhz-5A Annular Probe (B20-5A) ABSolu Console for connection with 15Mhz, 50Mhz and Biometry Probes including 2 Probe Holders, Footswitch, Protective Cover, Mouse Pad, Modern Update of Ocular and Orbital Ultrasound Monograph, E-User Manual, E-Quick Start, Power Cord ABSolu S including:Standardized A Probe, Biometry Probe ABSolu S and A/B Mode including:Standardized A Probe, 15Mhz B Probe (B1), Biometry Probe ABSolu S and B Mode including:Standardized A Probe, 15Mhz B Probe (B1) ABSolu S including:Standardized A Probe, Biometry Probe with Laser Aiming Beam (ProBeam?) ABSolu S and A/B Mode including:Standardized A Probe, 15Mhz B Probe (B1), Biometry Probe with Laser Aiming Beam (ProBeam?) ABSolu S including:Standardized A Probe ABSolu S and A/B Mode including:Standardized A Probe, 20Mhz-5A Annular Probe (B20-5A), Biometry Probe ABSolu A/B Mode including:Standardized A Probe, 20Mhz-5A Annular Probe (B20-5A), Biometry Probe with Laser Aiming Beam (ProBeam?) ABSolu S and B Mode including:Standardized A Probe, 20Mhz Annular B Probe S Upgrade * including Standardised A Probe and its ERM Board, Keycode, Tissue Model, Installation Software on USB Key 20 MHz Upgrade Biometry Probe Probeam 15 MHz Probe (B1) 50 MHz Linear Probe (BHF-50LIN)
Model Identifier(s)
PCBX0037A1AB PCBX0037A1B PCBX0037A1LAB PCBX0037A2AV PCBX0037A2LAV PCBX0037A2V PCBX0037ABS PCBX0037S1A PCBX0037S1AB PCBX0037S1B PCBX0037S1LA PCBX0037S1LAB PCBX0037S1S PCBX0037S2AV PCBX0037S2LAV PCBX0037S2V PCBX0037SUP PCBX0056 PCEX0009 PCEX0010 PCSX0005 PCSX0007