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Jeisys Potenza - HSA Registration DE0505157

Access comprehensive regulatory information for Jeisys Potenza in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0505157 and owned by Jeisys Medical Inc.. The device was registered on November 19, 2020.

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 C
DE0505157
Jeisys Potenza
HSA Registration Number: DE0505157
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Product Description

Fractional RF Microneedle Electrosurgical Unit is intended for use in dermatologic and electronic surgical procedures for electrocoagulation and hemostasis. Indication is Acne vulgaris.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General & Plastic Surgery
Registration Information
Registration Number
DE0505157
Registration Date
November 19, 2020
Change Notification Approval Date
January 21, 2025
Retention Due Date
November 18, 2025
Product Owner
Short Name
Jeisys Medical Inc.
Address
307, 308, 401, 410, Daeryung Techno Town 8th, 96, Gamasan-ro, Geumcheon-gu, Seoul 08501, Seoul, KOREA, REPUBLIC OF
Registrant
Address
19 KIM KEAT ROAD, FU TSU BUILDING, #06-01, SINGAPORE 328804
Importer
Address
19 KIM KEAT ROAD, FU TSU BUILDING, #06-01, SINGAPORE 328804
Model Information
Model Name(s)
Motor handpiece tip (Fractional) - ASSY TIP - I16 Motor handpiece tip (Fractional) - ASSY TIP - I25 Motor handpiece tip (Fractional) - ASSY TIP I49 Motor handpiece tip (Fractional) - ASSY TIP - C21-2 Motor handpiece tip (Fractional) - ASSY TIP - C21 -1 Motor handpiece tip (Fractional) - ASSY TIP - CP 9 AC Handpiece Tip P1-08 0.8mm AC Handpiece Tip A1-12 1.2mm AC Handpiece Tip A1-15 1.5mm Motor handpiece tip (Fractional) - ASSY TIP - S16 Motor handpiece tip (Fractional) - ASSY TIP - S25 Motor handpiece tip (Fractional) - ASSY TIP - S49 Motor handpiece tip (Fractional) - ASSY TIP - CP 21 Motor handpiece tip (Fractional) - ASSY TIP - CP-25 TIP Motor handpiece tip (Fractional) - ASSY TIP - CP-49 TIP Motor handpiece tip (Fractional) - ASSY TIP - CP-16 TIP Power Cord Neutral Electrode cable AC Handpiece Foot Switch Handpiece Stand Motor Handpiece Neutral Electrode Pad Potenza Main Unit
Model Identifier(s)
A01530A00 A01532A00 A01534A00 A01536A00 A01538A00 A01540A00 A01542A00 A01544A00 A01546A00 A01555A00 A01556A00 A01557A00 A01571A00 A02239A00 A02294A00 A02298A00 P03221A00 P03939A00 POZ-AHP-01 (A01529A00) POZ-FS-01 (A01548A00) POZ-HPS-01(P00140A00) POZ-MHP-01 (A01528A00) POZ-NEP-01(P03304A00) PZ0OS4