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Arthrex Thrombinator System - HSA Registration DE0508578

Access comprehensive regulatory information for Arthrex Thrombinator System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508578 and owned by Arthrex, Inc.. The device was registered on October 17, 2023.

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 B
DE0508578
Arthrex Thrombinator System
HSA Registration Number: DE0508578
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Product Description

Arthrex Thrombinator System is designed for the preparation of autologous serum from anticoagulated or non-anticoagulated peripheral blood, platelet poor plasma, or platelet rich plasma (PRP) that is to be mixed with PRP and autograft or allograft bone prior to application to a bony defect for improving handling characteristics.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0508578
Registration Date
October 17, 2023
Retention Due Date
October 16, 2025
Product Owner
Short Name
Arthrex, Inc.
Address
1370 Creekside Boulevard, Naples, Florida, 34108-1945, UNITED STATES
Registrant
Address
21 BIOPOLIS ROAD, NUCLEOS, #03-08, SINGAPORE 138567
Importer
Address
Nucleous 21 Biopolis Rd., #03-08, SINGAPORE 138567
Model Information
Model Name(s)
ThrombinatorTM System for use with Arthrexยฎ PRP Systems
Model Identifier(s)
ABS-10080