Singapore HSA registration DE0504142
Medtronic Riptide™ Aspiration System
Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0504142
- Registration Date
- February 21, 2020
- Change Notification Approval Date
- May 13, 2025
- Retention Due Date
- February 20, 2026
Product description
The Riptide™ Aspiration System is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
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
- Name
- COVIDIEN PRIVATE LIMITED MEDTRONIC INTERNATIONAL TRADING PTE. LTD. MEDTRONIC INTERNATIONAL, LTD.
- Address
- 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384 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)
- Riptide™ Collection Canister & Intermediate Tubing Riptide™ Aspiration Pump Riptide™ Aspiration Tubing
- Model Identifier(s)
- MAC-1200 MAP-1000EU MAT-110-110
About this record
Access comprehensive regulatory information for Medtronic Riptide™ Aspiration System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0504142 and owned by Micro Therapeutics, Inc. d/b/a EV3 Neurovascular. The device was registered on February 21, 2020.
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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