Pure Global

Genewel Guardix-SG Thermosensitive Adhesion Barrier - HSA Registration DE0017420

Access comprehensive regulatory information for Genewel Guardix-SG Thermosensitive Adhesion Barrier in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0017420 and owned by Genewel Co., Ltd. The device was registered on August 17, 2015.

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 Database
Powered by Pure Global AI
HSA Official Data
CLASS D
DE0017420
Genewel Guardix-SG Thermosensitive Adhesion Barrier
HSA Registration Number: DE0017420
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

It is used for the purpose of reducing the post-operative adhesions of opposing tissue around Spine or Thyroid surgery region. It is indicated for use as an adjunct in both open and laparoscopic procedures.

Device Classification
Device Class
CLASS D
Medical Speciality Area
General & Plastic Surgery
HSA Product Code
HSAMDD00107
HS Code
30061010
Registration Information
Registration Number
DE0017420
Registration Date
August 17, 2015
Change Notification Approval Date
December 12, 2024
Retention Due Date
August 16, 2025
Product Owner
Short Name
Genewel Co., Ltd
Address
6F, 37, Sagimakgol-ro 62 beon-gil,, Jungwon-gu, Seongnam-si,, Gyeonggi-do, KOREA, REPUBLIC OF
Registrant
Address
23 NEW INDUSTRIAL ROAD, SOLSTICE BUSINESS CENTER, #03-08, SINGAPORE 536209
Importer
Address
23 NEW INDUSTRIAL ROAD, SOLSTICE BUSINESS CENTER, #03-08, SINGAPORE 536209
Model Information
Model Name(s)
Guardix-SG 3g Guardix-SG 6g
Model Identifier(s)
GUARDIX-SGn-030 GUARDIX-SGn-060