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Singapore HSA registration DE0508943

BioRegen Biomedical MateRegen® Intrauterine Adhesion Barrier Gel

SingaporeCLASS DBioRegen Biomedical (Changzhou) Co., Ltd.Registered February 07, 2024
VerifiedHSA · official registry
Device classification
Device Class
CLASS D
Medical Speciality Area
General & Plastic Surgery
Registration information
Registration Number
DE0508943
Registration Date
February 07, 2024
Retention Due Date
February 06, 2026
Product description

MateRegen® Gel is indicated for use in patients after hysteroscopic surgeries as barrier to prevent or reduce post-operative intrauterine adhesions. MateRegen® Gel functions to fill intrauterine cavities following surgery, keep the traumatic surfaces separated during the healing process and act as an adjunct to facilitate the natural healing process.

Product Owner
Short Name
BioRegen Biomedical (Changzhou) Co., Ltd.
Address
Building B, No. 117, Xueye Road, 213125 Changzhou, Jiangsu, CHINA
Registrant
Address
50 FABER WALK, WATERFRONT @ FABER, #01-36, SINGAPORE 128994
Importer
Address
50 FABER WALK, WATERFRONT @ FABER, #01-36, SINGAPORE 128994
Model information
Model Name(s)
MateRegen® Gel 5ml Pack MateRegen® Gel 3ml Pack
Model Identifier(s)
40-008-005 40-008-011
About this record

Access comprehensive regulatory information for BioRegen Biomedical MateRegen® Intrauterine Adhesion Barrier Gel in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0508943 and owned by BioRegen Biomedical (Changzhou) Co., Ltd.. The device was registered on February 07, 2024.

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.