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Micro Therapeutics Pipeline™ Flex Embolization Device with Shield Technology™ - HSA Registration DE0018823

Access comprehensive regulatory information for Micro Therapeutics Pipeline™ Flex Embolization Device with Shield Technology™ in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0018823 and owned by Micro Therapeutics, Inc. d/b/a EV3 Neurovascular. The device was registered on December 21, 2016.

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
DE0018823
Micro Therapeutics Pipeline™ Flex Embolization Device with Shield Technology™
HSA Registration Number: DE0018823
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Product Description

The Pipeline™ Flex Embolization Device with Shield Technology™ is intended for endovascular embolization of cerebral aneurysms.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Neurology
Registration Information
Registration Number
DE0018823
Registration Date
December 21, 2016
Change Notification Approval Date
July 11, 2024
Retention Due Date
December 20, 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)
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Model Identifier(s)
PE2D-400-18 PED2-250-10 PED2-250-12 PED2-250-14 PED2-250-16 PED2-250-18 PED2-250-20 PED2-275-10 PED2-275-12 PED2-275-14 PED2-275-16 PED2-275-18 PED2-275-20 PED2-300-10 PED2-300-12 PED2-300-14 PED2-300-16 PED2-300-18 PED2-300-20 PED2-300-25 PED2-300-30 PED2-300-35 PED2-325-10 PED2-325-12 PED2-325-14 PED2-325-16 PED2-325-18 PED2-325-20 PED2-325-25 PED2-325-30 PED2-325-35 PED2-350-10 PED2-350-12 PED2-350-14 PED2-350-16 PED2-350-18 PED2-350-20 PED2-350-25 PED2-350-30 PED2-350-35 PED2-375-10 PED2-375-12 PED2-375-14 PED2-375-16 PED2-375-18 PED2-375-20 PED2-375-25 PED2-375-30 PED2-375-35 PED2-400-10 PED2-400-12 PED2-400-14 PED2-400-16 PED2-400-20 PED2-400-25 PED2-400-30 PED2-400-35 PED2-425-10 PED2-425-12 PED2-425-14 PED2-425-16 PED2-425-18 PED2-425-20 PED2-425-25 PED2-425-30 PED2-425-35 PED2-450-10 PED2-450-12 PED2-450-14 PED2-450-16 PED2-450-18 PED2-450-20 PED2-450-25 PED2-450-30 PED2-450-35 PED2-475-10 PED2-475-12 PED2-475-14 PED2-475-16 PED2-475-18 PED2-475-20 PED2-475-25 PED2-475-30 PED2-475-35 PED2-500-10 PED2-500-12 PED2-500-14 PED2-500-16 PED2-500-18 PED2-500-20 PED2-500-25 PED2-500-30 PED2-500-35