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DEKA SmartXide Touch C60 System - HSA Registration DE0019252

Access comprehensive regulatory information for DEKA SmartXide Touch C60 System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0019252 and owned by DEKA M.E.L.A. SRL. The device was registered on May 17, 2017.

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
DE0019252
DEKA SmartXide Touch C60 System
HSA Registration Number: DE0019252
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Product Description

The CO2 laser is intended for incision, excision, ablation, vaporisation and coagulation of body soft tissues, in medical specialties including aesthetic (Dermatology & plastic Surgery), Open and Endoscopic Surgery in: ENT, Gynaecology, Neurosurgery, General and Thoracic Surgery, Ophthalmology, Podiatry, Orthopaedics, Genitourinary Surgery, Dental and Oral Surgery.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General & Plastic Surgery
Registration Information
Registration Number
DE0019252
Registration Date
May 17, 2017
Change Notification Approval Date
October 22, 2018
Retention Due Date
May 16, 2025
Product Owner
Short Name
DEKA
Address
Via Baldanzese 17, 50041 Calenzano (FI), ITALY
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)
Mains cable Footswitch Footswitch 1.5" handpiece 2" handpiece 4" handpiece 7" handpiece Collimated handpiece HiScan DOT/RF unit HiScan V2LR unit SmartXide Touch C60 Interlock connector 4" dental handpiece for CO2 source (FL 2”) 2" dental handpiece for CO2 source (FL 2”)
Model Identifier(s)
CABLE13A E06301 E094B1 F26301 F26401 F26501 F26601 F26701 F26901 F27101 M110B1 N21901 N81501 N81601