Singapore HSA registration DE0509122
Medtronic Sofamor Danek Kyphon® Inflation Syringe
Singapore·CLASS B·Medtronic Sofamor Danek USA, Inc.·Registered March 28, 2024Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Orthopaedics
Registration information
- Registration Number
- DE0509122
- Registration Date
- March 28, 2024
- Retention Due Date
- March 27, 2026
Product description
The Kyphon® Inflation Syringe is intended to be used to inflate and deflate inflatable devices (including Inflatable Bone Tamps) and to measure the pressure within the inflatable device during the procedure.
Product Owner
- Short Name
- Medtronic Sofamor Danek USA, Inc.
- Address
- 1800 Pyramid Place, Memphis, TN 38132, 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 Sofamor Danek Kyphon® Inflation Syringe
- Model Identifier(s)
- A08E
About this record
Access comprehensive regulatory information for Medtronic Sofamor Danek Kyphon® Inflation Syringe in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509122 and owned by Medtronic Sofamor Danek USA, Inc.. The device was registered on March 28, 2024.
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B