Pure Global

Orthocell Striate+ - HSA Registration DE0510468

Access comprehensive regulatory information for Orthocell Striate+ in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0510468 and owned by Orthocell Ltd.. The device was registered on March 14, 2025.

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 Database
Powered by Pure Global AI
HSA Official Data
CLASS D
DE0510468
Orthocell Striate+
HSA Registration Number: DE0510468
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

Striate+™ is a sterile, resorbable collagen barrier membrane intended for use in guided bone and guided tissue regeneration. Striate+™ is indicated for use in: • Augmentation around implants placed in immediate extraction sockets • Augmentation around implants placed in delayed extraction sockets • Localized ridge augmentation for later implantation • Alveolar ridge reconstruction for prosthetic treatment • Filling of bone defects after root resection, cystectomy, removal of retained teeth • Guided bone regeneration in dehiscence defects; and • Guided tissue regeneration procedures in periodontal defects.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0510468
Registration Date
March 14, 2025
Retention Due Date
March 13, 2026
Product Owner
Short Name
Orthocell Ltd.
Address
Building 191, Murdoch University South Street, Murdoch WA 6150, AUSTRALIA
Registrant
Address
116 CHANGI ROAD, WIS@CHANGI, #04-05, SINGAPORE 419718
Importer
Address
9 RAFFLES PLACE, REPUBLIC PLAZA, #26-01, SINGAPORE 048619
Model Information
Model Name(s)
Striate+ Striate+ Striate+
Model Identifier(s)
OCG-152 OCG-203 OCG-304