Singapore HSA registration DE0502143
Micro Therapeutics Phenom™ Catheters
Device classification
- Device Class
- CLASS D
- Medical Speciality Area
- Neurology
Registration information
- Registration Number
- DE0502143
- Registration Date
- September 12, 2018
- Change Notification Approval Date
- July 11, 2024
- Retention Due Date
- September 11, 2025
Product description
Phenom™ Catheters are intended for the introduction of interventional devices or diagnostic agents into the peripheral, coronary, and neuro vasculature.
Product Owner
- Short Name
- ev3 Neurovascular
- Address
- 9775 Toledo Way,, Irvine, CA. 92618, 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
Model information
- Model Name(s)
- PHENOM™ CATHETER PHENOM™ CATHETER PHENOM™ CATHETER PHENOM™ CATHETER PHENOM™ CATHETER PHENOM™ CATHETER PHENOM™ CATHETER PHENOM™ CATHETER PHENOM™ CATHETER PHENOM™ CATHETER PHENOM™ CATHETER PHENOM™ CATHETER PHENOM™ CATHETER PHENOM™ CATHETER PHENOM™ CATHETER PHENOM™ CATHETER PHENOM™ CATHETER PHENOM™ CATHETER PHENOM™ CATHETER PHENOM™ CATHETER PHENOM™ CATHETER PHENOM™ CATHETER PHENOM™ CATHETER PHENOM™ CATHETER PHENOM™ CATHETER PHENOM™ CATHETER
- Model Identifier(s)
- FG11150-0615-2J FG11150-0615-2R FG11150-0615-2S FG11150-0615-2X FG11160-0615-1S FG11160-0615-2J FG11160-0615-2R FG11160-0615-2S FG11160-0615-2X FG13150-0615-2J FG13150-0615-2R FG13150-0615-2S FG13150-0615-2X FG13150-1015-2S FG13160-0615-1S FG15135-0615-1S FG15150-0615-1S FG15150-0630-1S FG15160-0615-1S FG19105-0615-1S FG19105-0630-1S FG19120-0630-1S FG19120-1015-1S FG19120-1030-1S FG19135-0615-1S FG19135-1030-1S
About this record
Access comprehensive regulatory information for Micro Therapeutics Phenom™ Catheters in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0502143 and owned by Micro Therapeutics, Inc. d/b/a EV3 Neurovascular. The device was registered on September 12, 2018.
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 D