HSA · registration DE0508578Arthrex Thrombinator System
SingaporeOrthopaedicsClass BArthrex, Inc.
Official record identity
- Registration number
- DE0508578
- Model name
- ThrombinatorTM System for use with Arthrex® PRP Systems
- Model identifier
- ABS-10080
- Registration date
- October 17, 2023
Classification
- Risk class
- Class B
Official value: CLASS B
Published parties
- Product owner
- Arthrex, Inc.
- Registrant / registration holder
- ARTHREX SINGAPORE, PTE. LTD.
Official 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.
Additional source fields
- Product owner address
- 1370 Creekside Boulevard, Naples, Florida, 34108-1945, United States
- Registrant address
- Nucleous 21 Biopolis Rd., #03-08, Singapore 138567
About this record
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.