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Medtronic Urchin® EVO Heart Positioner - HSA Registration DE0013192

Access comprehensive regulatory information for Medtronic Urchin® EVO Heart Positioner in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0013192 and owned by Medtronic Inc. The device was registered on June 24, 2013.

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 B
DE0013192
Medtronic Urchin® EVO Heart Positioner
HSA Registration Number: DE0013192
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Product Description

Intended for use during coronary artery bypass grafting operations. The intended function of this product is for positioning the heart.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Cardiovascular
HSA Product Code
HSAMDA00110
HS Code
90189090
Registration Information
Registration Number
DE0013192
Registration Date
June 24, 2013
Change Notification Approval Date
December 09, 2022
Retention Due Date
June 23, 2025
Product Owner
Short Name
Medtronic
Address
8200 Coral Sea Street, MS MVS11, Mounds View, MN 55112, UNITED STATES
Registrant
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Importer
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Model Information
Model Name(s)
Medtronic Urchin EVO HP3500 Heart Positioner
Model Identifier(s)
HP3500