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Jeisys Edge One CO2 Laser Surgical Unit - HSA Registration DE0505177

Access comprehensive regulatory information for Jeisys Edge One CO2 Laser Surgical Unit in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0505177 and owned by Jeisys Medical Inc.. The device was registered on November 26, 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
DE0505177
Jeisys Edge One CO2 Laser Surgical Unit
HSA Registration Number: DE0505177
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Product Description

The CO2 Laser Surgical Unit is indicated for use in surgical procedures with intent to incise, destroy and remove tissues using radiated optical energy (CO2 laser).

Device Classification
Device Class
CLASS C
Medical Speciality Area
General & Plastic Surgery
Registration Information
Registration Number
DE0505177
Registration Date
November 26, 2020
Retention Due Date
November 25, 2025
Product Owner
Short Name
Jeisys Medical Inc.
Address
307, 308, 401, Daeryung Techno Town, 96 Gamasan-ro, Geumcheon-gu, Seoul, KOREA, REPUBLIC OF
Registrant
Address
160 PAYA LEBAR ROAD, ORION @ PAYA LEBAR, #04-03, SINGAPORE 409022
Importer
Address
160 PAYA LEBAR ROAD, ORION @ PAYA LEBAR, #04-03, SINGAPORE 409022
Model Information
Model Name(s)
Edge ONE Fractional Handpiece Surgical Handpiece 120S Tip 120 Tip 350 Tip 800 Tip Surgical Tip Foot Switch Power Cord Eyes Protector for practitioner Eyes protector for patient
Model Identifier(s)
EO-1001 EO-1002 EO-1003 EO-1004 EO-1005 EO-1006 EO-1007 EO-1008 EO-1009 EO-1010 EO-1011 EO-1012