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Iskra Medical Tesla Former Prestige - HSA Registration DE0507164

Access comprehensive regulatory information for Iskra Medical Tesla Former 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 DE0507164 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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CLASS B
DE0507164
Iskra Medical Tesla Former Prestige
HSA Registration Number: DE0507164
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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

Device Classification
Device Class
CLASS B
Medical Speciality Area
General & Plastic Surgery
Registration Information
Registration Number
DE0507164
Registration Date
August 16, 2022
Retention Due Date
August 15, 2025
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 FMS2 M Former Applicator FMS2 L Former Arm for Applicator FMS Chair for incontinence 2 app Tesla Former Prestige
Model Identifier(s)
15113053 15113063 1600631 1600649 1800587