Singapore HSA registration DE0017420
Genewel Guardix-SG Thermosensitive Adhesion Barrier
Singapore·CLASS D·Genewel Co., Ltd·Registered August 17, 2015Device 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 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.
Product Owner
- Name
- Genewel Co., Ltd
- 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
About this record
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.
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