Singapore HSA registration DE0507165
Iskra Medical Tesla Care Prestige
Singapore·CLASS B·Iskra Medical d.o.o·Registered August 16, 2022Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General & Plastic Surgery
Registration information
- Registration Number
- DE0507165
- Registration Date
- August 16, 2022
- Retention Due Date
- August 15, 2025
Product description
Device is to be used as an adjunct therapy for the proposed medical indications: • Improvement in colon mobility of patients diagnosed with neurological bowel dysfunction characterized by severe constipation • Improvement in quality of life of patients diagnosed with intractable constipation caused by neurological bowel dysfunction • Improvement of quality of life of patients diagnosed with urinary incontinence • Mitigate the occurrence of stress-induced urinary incontinence for female • Relieve chronic lower back pain • Relieve pain associated with chronic prostatitis/chronic pelvic pain syndrome for male who are not responsive to pharmacotherapy
Product Owner
- Short Name
- Iskra Medical d.o.o
- Address
- Stegne 23, 1000, Ljubljana, SLOVENIA
Registrant
- Address
- 6 TAGORE DRIVE, TAGORE INDUSTRIAL BUILDING, #04-06/07, SINGAPORE 787623
Importer
- Address
- 6 TAGORE DRIVE, TAGORE INDUSTRIAL BUILDING, #04-06/07, SINGAPORE 787623
Model information
- Model Name(s)
- Applicator FMS Medium Applicator FMS large Arm for Applicator FMS Chair for incontinence 2 app Tesla Care Prestige
- Model Identifier(s)
- 1511305 1511306 1600631 1600635 1800544
About this record
Access comprehensive regulatory information for Iskra Medical Tesla Care Prestige in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0507165 and owned by Iskra Medical d.o.o. The device was registered on August 16, 2022.
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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