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Biomet nSTRIDE APS Kit - HSA Registration DE0503253

Access comprehensive regulatory information for Biomet nSTRIDE APS Kit in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0503253 and owned by Biomet Orthopedics. The device was registered on June 19, 2019.

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
DE0503253
Biomet nSTRIDE APS Kit
HSA Registration Number: DE0503253
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Product Description

The nSTRIDE APS Kit is designed to be used for the safe and rapid preparation of autologous protein solution (APS) from a small sample of blood at the patient’s point of care.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0503253
Registration Date
June 19, 2019
Change Notification Approval Date
November 03, 2022
Retention Due Date
June 18, 2025
Product Owner
Short Name
Biomet
Address
56 East Bell Drive, P O Box 587, Warsaw, IN 46581, 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)
nSTRIDE APS Kit
Model Identifier(s)
800-3000ST