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Emblation Limited Swift ® System - HSA Registration DE0506770

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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CLASS C
DE0506770
Emblation Limited Swift ® System
HSA Registration Number: DE0506770
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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.

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 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