Singapore HSA registration DE0508579BioRegen Biomedical PureRegen® Gel Nasal and Sinus dressing
- Device Class
- CLASS B
- Medical Speciality Area
- Ear, Nose & Throat
- Registration Number
- DE0508579
- Registration Date
- October 17, 2023
- Retention Due Date
- October 16, 2025
PureRegen® Gel Sinus is indicated for use in patients after nasal and sinus surgery as a space occupying dressing and/or stent intended to prevent adhesions in the nasal cavity, separate mucosal surfaces, help control minimal bleeding following surgery, and act as an adjunct to facilitate the natural healing process. The device is indicated following nasal and sinus surgery to prevent lateralization of the middle turbinate during the post-operative period.
- Short Name
- BioRegen Biomedical (Changzhou) Co., Ltd.
- Address
- Building B, No. 117, Xueye Road, 213125 Changzhou, Jiangsu, CHINA
- Address
- 50 FABER WALK, WATERFRONT @ FABER, #01-36, SINGAPORE 128994
- Address
- 50 FABER WALK, WATERFRONT @ FABER, #01-36, SINGAPORE 128994
- Model Name(s)
- PureRegen® Gel Sinus 5ml
- Model Identifier(s)
- 40-011-005
Access comprehensive regulatory information for BioRegen Biomedical PureRegen® Gel Nasal and Sinus dressing in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508579 and owned by BioRegen Biomedical (Changzhou) Co., Ltd.. The device was registered on October 17, 2023.
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.