Singapore HSA registration DE0015210
Medtronic ACT Plus® System
Singapore·CLASS C IVD·Medtronic, Inc.·Registered April 21, 2014Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Clinical chemistry
- HSA Product Code
- HSAMDC00106
- HS Code
- 38220090
Registration information
- Registration Number
- DE0015210
- Registration Date
- April 21, 2014
- Change Notification Approval Date
- April 02, 2025
- Retention Due Date
- April 20, 2026
Product description
The Medtronic ACT Plus® Automated Coagulation Timer is a microprocessor-controlled electromechanical coagulation instrument intended for in vitro determination of coagulation endpoints in fresh and citrated whole blood samples. The ACT Plus® instrument is designed for use with the following Medtronic disposable cartridges: High-Range ACT, Low-Range ACT, Recalcified ACT, and High-Range Heparinase.
Product Owner
- Name
- Medtronic, Inc.
- Short Name
- Medtronic
- Address
- 710 Medtronic Parkway NE, MN, 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)
- Actuator Cleaning kit Temperature Verification Cartridge for ACT Plus® HEPline Kit ACTtrac® Electronic Control for ACT Plus® Low Range Activated Clotting Time (HR ACT™ ) Recalcified Activated Clotting Time (RACT™ ) High Range Activated Clotting Time (HR ACT™ ) Heparinase Test Cartirdge (HTC) CLOTtrac® CWB Control (normal) - for Low RangeACT® and RACT cartridges CLOTtrac® HR Coagulation Control CLOTtrac® HR Abnormal Coagulation Control CLOTtrac® LR Abnormal Coagulation Control CLOTtrac® RACT abnormal Coatulation Control Calcium Chloride - for use with the low Range ACT contols CLOTtrac® HTC Coagulation Control CLOTtrac® HR Control Pack ACT Plus® instrument ACT Plus® instrument Outside US Version ACT Plus® External Data Manager Software Low Range ACT Easy Fill Accessory High Range ACT Easy Fill Accessory ACT Plus® Bar Code Scanner
- Model Identifier(s)
- 303-58 313-11 313-50 31363 402-01 402-02 402-03 402-07 550-01 550-07 550-08 550-09 550-10 550-11 550-12 550-13 ACT100 ACT200 ACTEDM ACTFILLR ACTFLHR ACTSC
About this record
Access comprehensive regulatory information for Medtronic ACT Plus® System in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0015210 and owned by Medtronic, Inc.. The device was registered on April 21, 2014.
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 C IVD