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Micro Therapeutics Phenom™ Catheters - HSA Registration DE0502143

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.

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CLASS D
DE0502143
Micro Therapeutics Phenom™ Catheters
HSA Registration Number: DE0502143
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Product Description

Phenom™ Catheters are intended for the introduction of interventional devices or diagnostic agents into the peripheral, coronary, and neuro vasculature.

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 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