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botiss collacone® Collagenic hemostat (cone) - HSA Registration DE0506645

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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CLASS D
DE0506645
botiss collacone® Collagenic hemostat (cone)
HSA Registration Number: DE0506645
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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.

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 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