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botiss collafleece® Collagenic hemostat (sponge) - HSA Registration DE0506644

Access comprehensive regulatory information for botiss collafleece® Collagenic hemostat (sponge) in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0506644 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
DE0506644
botiss collafleece® Collagenic hemostat (sponge)
HSA Registration Number: DE0506644
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Product Description

collafleece® is a wet-stable collagen sponge, promotes wound healing and serves as a hemostatic agent. The use of collafleece® is indicated wherever capillary, venous, small arterial and diffuse seeping bleedings require hemostasis and where conventional methods of hemostasis are either inadequate or technically difficult and time-consuming. collafleece® is indicated for the support of wound healing and control of bleeding in the following areas of application: - Protection and hemostatic treatment of minor oral wounds, - Protection of the Schneiderian membrane, - Covering of biopsy or transplant harvesting sites, - Protection and hemostatic treatment after tooth extraction.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0506644
Registration Date
February 11, 2022
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)
collafleece Collagenic hemostat (Sponge)
Model Identifier(s)
512212