Singapore HSA registration DE0506136
Geistlich Fibro-Gide®
Device classification
- Device Class
- CLASS D
- Medical Speciality Area
- Dental
Registration information
- Registration Number
- DE0506136
- Registration Date
- September 02, 2021
- Change Notification Approval Date
- November 28, 2023
- Retention Due Date
- September 01, 2025
Product description
Geistlich Fibro-Gide® is intended to be used as an implantable device for regeneration and augmentation of soft tissue in oral and maxillofacial surgery. Indications Geistlich Fibro-Gide® is indicated to be used in the surgical treatment of the following clinical conditions in the oral and maxillofacial area: Defects and deficiencies of soft tissue associated with: - Presence of recessions* - Lack of soft-tissue volume The defects and deficiencies may result from traumatic injuries, pathological conditions (congenital or acquired), medical treatments and therapies, or from history of personal lifestyle habits. *Data on the use of the product in recession defects Miller Class III and IV is currently not available
Product Owner
- Short Name
- Geistlich Pharma AG
- Address
- Bahnhofstrasse 40, CH-6110 Wolhusen, SWITZERLAND
Registrant
- Address
- 6 UBI ROAD 1, WINTECH CENTRE, #04-01, SINGAPORE 408726
Importer
- Address
- 6 UBI ROAD 1, WINTECH CENTRE, #04-01, SINGAPORE 408726
Model information
- Model Name(s)
- Geistlich Fibro-Gide ® Geistlich Fibro-Gide ® Geistlich Fibro-Gide® Geistlich Fibro-Gide®
- Model Identifier(s)
- 500234 500239 500665 500666
About this record
Access comprehensive regulatory information for Geistlich Fibro-Gide® in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0506136 and owned by Geistlich Pharma AG. The device was registered on September 02, 2021.
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS D