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Fotona StarFormer - HSA Registration DE0509654

Access comprehensive regulatory information for Fotona StarFormer in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509654 and owned by Fotona d.o.o. The device was registered on August 14, 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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CLASS B
DE0509654
Fotona StarFormer
HSA Registration Number: DE0509654
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Product Description

The StarFormer Family of devices and their accessories are intended for magnetic stimulation in the field of Gynecology and Urology, Pain Management and Rehabilitation and Physiotherapy. For Gynecology and Urology, it is indicated for Stimulation of pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of male and female urinary incontinence and other pelvic floor disorders. For Rehabilitation and Physiotherapy, it is indicated for Rehabilitation of motor control impairments due to disease or injury.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Physical Medicine
Registration Information
Registration Number
DE0509654
Registration Date
August 14, 2024
Retention Due Date
August 13, 2025
Product Owner
Short Name
Fotona d.o.o
Address
Stegne 7, 1000 Ljubljana, SLOVENIA
Registrant
Address
111 NORTH BRIDGE ROAD, PENINSULA PLAZA, #21-01, SINGAPORE 179098
Importer
Address
1004 TOA PAYOH NORTH, #06-10, SINGAPORE 318995
Model Information
Model Name(s)
IntimaWave Chair Applicator StarFormer Applicator Applicator
Model Identifier(s)
IntimaWave Chair Large StarFormer M008-3T Radial Large StarFormer Radial XLarge StarFormer