Singapore HSA registration DE0506645
botiss collacone® Collagenic hemostat (cone)
Device classification
- Device Class
- CLASS D
- Medical Speciality Area
- Dental
Registration information
- Registration Number
- DE0506645
- Registration Date
- February 11, 2022
- Change Notification Approval Date
- August 03, 2023
- Retention Due Date
- February 10, 2026
Product description
collacone® is indicated wherever capillary, venous, small arterial and diffuse seeping bleedings must be stopped, and where conventional means of haemorrhage control are either inadequate or technically difficult and time-consuming. collacone® is used as a hemostatic agent and to stabilize the blood coagulum i.e. - following tooth extraction (also in patients at risk of bleeding) - in Internal sinus lift procedures - to cover immediately placed implants - in bone or soft tissue defects e.g. following biopsy or transplant harvesting or cystectomy.
Product Owner
- Short Name
- botiss biomaterials GmbH
- Address
- Hauptstr. 28, 15806 Zossen, GERMANY
Registrant
- Address
- 73 UBI ROAD 1, OXLEY BIZHUB, #10-61/62, SINGAPORE 408733
Importer
- Address
- 73 UBI ROAD 1, OXLEY BIZHUB, #10-61/62, SINGAPORE 408733
Model information
- Model Name(s)
- collacone COLLAGEN HEMOSTAT (CONE)
- Model Identifier(s)
- 511112
About this record
Access comprehensive regulatory information for botiss collacone® Collagenic hemostat (cone) in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0506645 and owned by botiss biomaterials GmbH. The device was registered on February 11, 2022.
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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