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RELIGN Tricera System - HSA Registration DE0509743

Access comprehensive regulatory information for RELIGN Tricera System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0509743 and owned by RELIGN Corporation. The device was registered on September 06, 2024.

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 C
DE0509743
RELIGN Tricera System
HSA Registration Number: DE0509743
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Product Description

The Tricera System is indicated for use in orthopedic and arthroscopic procedures. The Fluid Management System of the Tricera Arthroscopic System provides fluid distension and irrigation of the knee, shoulder, ankle, elbow, wrist and hip, and fluid suction during diagnostic and operative arthroscopic procedures. The Shaver Blade/RF Probe of the Tricera Arthroscopic System provides abrasion, resection, debridement, and removal of bone through its shaver blade; removal, ablation, and coagulation of soft tissue; as well as hemostasis of blood vessels through its shaver blade and probe. Examples of uses of the product include resection of torn knee cartilage, subacromial decompression, and resection of synovial tissue in other joints.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0509743
Registration Date
September 06, 2024
Retention Due Date
September 05, 2025
Product Owner
Short Name
RELIGN Corporation
Address
655 Campbell Technology Parkway, Su, Campbell, California 95008, UNITED STATES
Registrant
Address
401 COMMONWEALTH DRIVE, HAW PAR TECHNO CENTRE, #06-03, SINGAPORE 149598
Importer
Address
401 COMMONWEALTH DRIVE, HAW PAR TECHNO CENTRE, #06-03, SINGAPORE 149598
Model Information
Model Name(s)
RF CONTROLLER Veriflowโ„ข Dynablatorโ„ข 3-in-1 Shaverโ„ข 4.2 mm Standard Shaver 3.4 mm 3-in-1 Shaverโ„ข 5.0 mm Exoflowโ„ข Standard Burr 5.0 mm Triceraโ„ข Handpiece, Autoclavable Curved Standard Shaver 3.4mm
Model Identifier(s)
R-10001 R-10003 R-10005 R-10008 R-10012 R-10014 R-10017 R-10021 R-10023 R-10024