Singapore HSA registration DE0509654
Fotona StarFormer
Singapore·CLASS B·Fotona d.o.o·Registered August 14, 2024Device 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 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.
Product Owner
- Name
- Fotona d.o.o
- 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
About this record
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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