Singapore HSA registration DE0505157
Jeisys Potenza
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 description
Fractional RF Microneedle Electrosurgical Unit is intended for use in dermatologic and electronic surgical procedures for electrocoagulation and hemostasis. Indication is Acne vulgaris.
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
About this record
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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