Singapore HSA registration DE0013192
Medtronic Urchin® EVO Heart Positioner
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 description
Intended for use during coronary artery bypass grafting operations. The intended function of this product is for positioning the heart.
Product Owner
- Name
- Medtronic Inc
- 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
About this record
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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