Singapore HSA registration DE0510517
DEKA SmartXide Tetra PRO
Singapore·CLASS C·DEKA M.E.L.A. SRL·Registered March 27, 2025Device 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 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.
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 V²LR PRO V²LR PRO SmartXide Tetra PRO
- Model Identifier(s)
- F26301 F26401 F26501 F26601 F26701 F477D1 F54001 F540A1 F540B1 F54101 M118F1
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C