Singapore HSA registration DE0506770
Emblation Limited Swift ® System
Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General & Plastic Surgery
Registration information
- Registration Number
- DE0506770
- Registration Date
- April 01, 2022
- Change Notification Approval Date
- July 15, 2024
- Retention Due Date
- March 31, 2026
Product description
The Swift® generator is intended to be used with the Swift ®applicator for the coagulation of soft tissue for surface dermal conditions. The Swift® microwave tissue ablation system is for microwave treatments in the fields of Podiatry and Dermatology. Swift® should be used by clinicians trained by Emblation or their authorised representatives. Swift® should only be used in a clinical setting including clinics or consultation offices.
Product Owner
- Short Name
- Emblation Limited
- Address
- Emblation House, Castle Business Park, Stirling FK9 4TS, Scotland, UNITED KINGDOM
Registrant
- Address
- 1 HARBOURFRONT PLACE, HARBOURFRONT TOWER ONE, #11-01-03, SINGAPORE 098633
Importer
- Address
- 140 PAYA LEBAR ROAD, AZ @ PAYA LEBAR, #06-03, SINGAPORE 409015
Model information
- Model Name(s)
- Swift® Applicator Tip Swift® Interconnect Cable Swift® Microwave Generator Swift® Applicator Handpiece
- Model Identifier(s)
- SWF-AT01 SWF-CA01 SWF-GE01 SWF-HP01
About this record
Access comprehensive regulatory information for Emblation Limited Swift ® 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 DE0506770 and owned by Emblation Limited. The device was registered on April 01, 2022.
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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