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Singapore HSA registration DE0508382

Tornier Blueprint 3D Planning Software with Patient-specific Instruments (PSI)

Singapore flagSingapore·CLASS B·Tornier SAS·Registered August 15, 2023
Device classification
Device Class
CLASS B
Medical Speciality Area
Orthopaedics
Registration information
Registration Number
DE0508382
Registration Date
August 15, 2023
Retention Due Date
August 14, 2025
Product description
Blueprint 3D Planning Software is a medical device for surgeons. It is intended to be used as a pre- surgical planner for shoulder replacement surgery, for adult men and women patients only whose bone maturity is reached. The BLUEPRINT™ Glenoid Guides are patient-specific drill guides, intended to be used as surgical instruments to assist in the intraoperative positioning of glenoid components used with total anatomic or reversed shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT- scans.
Product Owner
Name
Tornier SAS
Short Name
Tornier SAS
Address
161 Rue Lavoisier, 38330 Montbonnot-Saint-Martin, FRANCE
Registrant
Name
STRYKER SINGAPORE PRIVATE LIMITED
Address
1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145
Importer
Name
DKSH SINGAPORE PTE. LTD. STRYKER SINGAPORE PRIVATE LIMITED
Address
47 JALAN BUROH, #09-01, SINGAPORE 619491 1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145
Model information
Model Name(s)
BLUEPRINT PERFORM GLENOID GUIDE + BLUEPRINT GLENOID BONE MODEL MWJ013 (height: 33.5-76mm, width: 33-58mm, depth: 12.75-35mm) BLUEPRINT REVERSED GLENOID GUIDE + BLUEPRINT GLENOID BONE MODEL MWJ013 (height: 33.5-76mm, width: 33-58mm, depth: 12.75-35mm) BLUEPRINT REUSABLE PIN GUIDE BLUEPRINT PERFORM+ GLENOID GUIDE + BLUEPRINT GLENOID BONE MODEL MWJ013 (height: 33.5-76mm, width: 33-58mm, depth: 12.75-35mm) BLUEPRINT 3D PLANNING SOFTWARE
Model Identifier(s)
MWJ003 (height, width, depth) MWJ004 (height, width, depth) MWJ020 MWJ021 (height, width, depth) N/A
About this record

Access comprehensive regulatory information for Tornier Blueprint 3D Planning Software with Patient-specific Instruments (PSI) in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508382 and owned by Tornier SAS. The device was registered on August 15, 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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