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DEKA SmartXide Tetra PRO - HSA Registration DE0510517

Access comprehensive regulatory information for DEKA SmartXide Tetra PRO in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0510517 and owned by DEKA M.E.L.A. SRL. The device was registered on March 27, 2025.

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
DE0510517
DEKA SmartXide Tetra PRO
HSA Registration Number: DE0510517
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Product Description

The SmartXide Tetra PRO is a medical device indicated for incision, excision, ablation, vaporization and coagulation of body soft tissue, in dermatology, gynaecology (including vaginal atrophy treatment), genitourinary surgery and plastic surgery.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General & Plastic Surgery
Registration Information
Registration Number
DE0510517
Registration Date
March 27, 2025
Retention Due Date
March 26, 2026
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)
FL 1,5" Handpiece FL 2.0" Handpiece FL 4.0" Handpiece FL 7.0" Handpiece Collimated handpiece DermaSCAN DOT PRO SCAR 3 PRO VยฒLR PRO VยฒLR PRO SmartXide Tetra PRO
Model Identifier(s)
F26301 F26401 F26501 F26601 F26701 F477D1 F54001 F540A1 F540B1 F54101 M118F1