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Stryker AutoPlex™ Mixer and Delivery System - HSA Registration DE0008778

Access comprehensive regulatory information for Stryker AutoPlex™ Mixer and Delivery 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 DE0008778 and owned by Stryker Instruments. The device was registered on March 07, 2012.

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
DE0008778
Stryker AutoPlex™ Mixer and Delivery System
HSA Registration Number: DE0008778
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Product Description

The Stryker AutoPlex™ System is used for mixing bone cement and delivering the bone cement percutaneously.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0008778
Registration Date
March 07, 2012
Change Notification Approval Date
June 27, 2024
Retention Due Date
March 06, 2026
Product Owner
Short Name
Stryker Instruments
Address
1941 Stryker Way, Portage MI 49002, UNITED STATES
Registrant
Address
1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145
Importer
Address
1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145 5 JALAN KILANG BARAT, PETRO CENTRE, #09-00, SINGAPORE 159349
Model Information
Model Name(s)
11 Gauge Autoplex™ System With Vertaplex™ (2/PKG) 13 Gauge Autoplex™ System With Vertaplex™ (2/PKG) Autoplex™ System With Vertaplex w/o Needles (2/PKG) Autoplex™ System Kit without Cement or Needles
Model Identifier(s)
605-683 605-685 605-687 605-887