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Geistlich Fibro-Gide® - HSA Registration DE0506136

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.

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CLASS D
DE0506136
Geistlich Fibro-Gide®
HSA Registration Number: DE0506136
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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

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 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