Pure Global
Singapore HSA registration DE0012740

DEKA SmartXide2 System

Singapore flagSingapore·CLASS C·DEKA M.E.L.A. SRL·Registered April 09, 2013
Device classification
Device Class
CLASS C
Medical Speciality Area
General & Plastic Surgery
Registration information
Registration Number
DE0012740
Registration Date
April 09, 2013
Change Notification Approval Date
October 20, 2022
Retention Due Date
April 08, 2026
Product description
CO2 laser source indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including dermatology & plastic surgery, general surgery, otolaryngology (ENT), neurosurgery, gynaecology and genitourinary surgery (including vaginal atrophy treatment). Diode laser source indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in surgical specialties including otolaryngology (ENT).
Product Owner
Name
DEKA M.E.L.A. SRL
Short Name
DEKA
Address
Via Baldanzese 17, 50041 Calenzano (FI), ITALY
Registrant
Name
NEOASIA (S) PTE LTD
Address
6 TAGORE DRIVE, TAGORE INDUSTRIAL BUILDING, #04-06/07, SINGAPORE 787623
Importer
Name
EASMED ASIA PTE LTD NEOASIA (S) PTE LTD
Address
11 LORONG 3 TOA PAYOH, JACKSON SQUARE, #01-13, SINGAPORE 319579 6 TAGORE DRIVE, TAGORE INDUSTRIAL BUILDING, #04-06/07, SINGAPORE 787623
Model information
Model Name(s)
Straight endonasal probe 86mm 90° endonasal probe 86mm 1*150mm cannula 1*100mm cannula 1*200mm cannula 1*250mm cannula 1.4*150mm cannula 1.4*250mm cannula 1.4*100mm cannula 1.4*200mm cannula 200μm fiber 200μm fiber reusable 300μm fiber 300μm fiber reusable 600μm fiber 600μm fiber reusable Monalisa Full Handpiece 980nm 50W diode laser module 980nm 30W diode laser module 1.5" handpiece 2" handpiece 4" handpiece 7" handpiece Collimated handpiece EndoScan unit HiScan DOT/RF unit HiScan SCAR 3 HiScan Surgical unit HiScan V2LR unit Endonasal probes kit 86mm 5" handpiece 8" handpiece SmartXide2 Trio C60H SmartXide2 C60 SmartXide2 C40 Diode handpiece Micromanipulator EasySpot Micromanipulator EasySpot Hybrid Handpiece for endonasal probes Manipolo 2" Slim cut 300mm focal for laparoscope 400mm focal for laparoscope Hollow flexible waveguide 86mm 90° single-mirror vaginal probe 90° open single-mirror vaginal probe 16mm 90° single-mirror vaginal probe
Model Identifier(s)
04283016A 04283018B 04300017C 04300018C 04300019C 04300020C 04300022C 04300023C 04300024C 04300025C 070200186 070200187 070200188 070200189 070200190 070200191 070600002 F26201 F262B1 F26301 F26401 F26501 F26601 F26701 F26801 F26901 F269D1 F27001 F27101 F27901 F28001 F28101 M103AJ1 M103F1 M103G1 N10101 N183C1 N183F1 N34601 N37701 N75901 N759A1 N76501 N94601 N94701 N97701
About this record

Access comprehensive regulatory information for DEKA SmartXide2 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 DE0012740 and owned by DEKA M.E.L.A. SRL. The device was registered on April 09, 2013.

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS C