Pure Global AI
Singapore HSA registration DE0508942

BioRegen Biomedical HyaRegen® Absorbable 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
DE0508942
Registration Date
February 07, 2024
Retention Due Date
February 06, 2026
Product description

HyaRegen® Gel is indicated for the prevention or reduction post surgical adhesion formation in the abdomino pelvic area after laparoscopic/hysteroscopic and open gynaecological surgical procedures.

Product Owner
Name
BioRegen Biomedical (Changzhou) Co., Ltd.
Short Name
BioRegen Biomedical (Changzhou) Co., Ltd.
Address
Building B, No. 117, Xueye Road, 213125 Changzhou, Jiangsu, CHINA
Registrant
Name
VENCARE PTE. LTD.
Address
50 FABER WALK, WATERFRONT @ FABER, #01-36, SINGAPORE 128994
Importer
Name
VENCARE PTE. LTD.
Address
50 FABER WALK, WATERFRONT @ FABER, #01-36, SINGAPORE 128994
Model information
Model Name(s)
HyaRegen® Gel 10ml Pack
Model Identifier(s)
40-012-010
About this record

Access comprehensive regulatory information for BioRegen Biomedical HyaRegen® Absorbable 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 DE0508942 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.