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Singapore HSA registration DE0508578

Arthrex Thrombinator System

Singapore flagSingapore·CLASS B·Arthrex, Inc.·Registered October 17, 2023
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 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.
Product Owner
Name
Arthrex, Inc.
Short Name
Arthrex, Inc.
Address
1370 Creekside Boulevard, Naples, Florida, 34108-1945, UNITED STATES
Registrant
Name
ARTHREX SINGAPORE, PTE. LTD.
Address
21 BIOPOLIS ROAD, NUCLEOS, #03-08, SINGAPORE 138567
Importer
Name
ARTHREX SINGAPORE PTE LTD
Address
Nucleous 21 Biopolis Rd., #03-08, SINGAPORE 138567
Model information
Model Name(s)
ThrombinatorTM System for use with Arthrex® PRP Systems
Model Identifier(s)
ABS-10080
About this record

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B