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Singapore HSA registration DE0016891

Genewel Guardix-Sol Adhesion Barrier

Singapore flagSingapore·CLASS D·Genewel Co., Ltd·Registered March 02, 2015
Device classification
Device Class
CLASS D
Medical Speciality Area
General & Plastic Surgery
HSA Product Code
HSAMDD00107
HS Code
30061010
Registration information
Registration Number
DE0016891
Registration Date
March 02, 2015
Change Notification Approval Date
December 12, 2024
Retention Due Date
March 01, 2026
Product description
Guardix-Sol Adhesion Barrier is intended to be applied to sites of potentially adhesiogenic tissue and organ structures to serve as a temporary mechanical separating apposing tissue surfaces. It is indicated for use as an adjunct in both open and laproscopic procedures, (General, Gyn, Spine, ENT, Orthopaedic surgery etc.) intended to reduce the incidence, extent and severity of postoperative adhesions at the surgical site.
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
Name
NOVEM HEALTHCARE PTE LTD
Address
23 NEW INDUSTRIAL ROAD, SOLSTICE BUSINESS CENTER, #03-08, SINGAPORE 536209
Importer
Name
NOVEM HEALTHCARE PTE LTD
Address
23 NEW INDUSTRIAL ROAD, SOLSTICE BUSINESS CENTER, #03-08, SINGAPORE 536209
Model information
Model Name(s)
Guardix-Sol (5g) Guardix-Sol (1.5g)
Model Identifier(s)
Guardix-Sol01 Guardix-Sol02
About this record

Access comprehensive regulatory information for Genewel Guardix-Sol 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 DE0016891 and owned by Genewel Co., Ltd. The device was registered on March 02, 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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