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Singapore HSA registration DE0506166

NeuroVasc Technologies Envi™-SR Retriever for Mechanical Thrombectomy

Singapore flagSingapore·CLASS D·NeuroVasc Technologies, Inc.·Registered September 13, 2021
Device classification
Device Class
CLASS D
Medical Speciality Area
Neurology
Registration information
Registration Number
DE0506166
Registration Date
September 13, 2021
Change Notification Approval Date
October 29, 2024
Retention Due Date
September 12, 2025
Product description
The Envi™-SR is intended for use to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for IV tPA or who fail IV tPA therapy are candidates for treatment.
Product Owner
Name
NeuroVasc Technologies, Inc.
Short Name
NeuroVasc Technologies, Inc.
Address
3 Jenner, Ste. 100, Irvine, CA, 92618, Irvine, CA 92618, UNITED STATES
Registrant
Name
IMPLANTEX PTE. LTD.
Address
HONGKONG STREET, HOLY BUILDING, #03-01, SINGAPORE 059675
Model information
Model Name(s)
Envi-SR Retriever for Mechanical Thrombectomy 3x10 Envi-SR Retriever for Mechanical Thrombectomy 3x15 Envi-SR Retriever for Mechanical Thrombectomy 3x20 Envi-SR Retriever for Mechanical Thrombectomy 4x25 Envi-SR Retriever for Mechanical Thrombectomy 4x35 Envi-SR Retriever for Mechanical Thrombectomy 4x45 Envi-SR Retriever for Mechanical Thrombectomy 5x30 Envi-SR Retriever for Mechanical Thrombectomy 5x40 Envi-SR Retriever for Mechanical Thrombectomy 5x55
Model Identifier(s)
FG-004-001 FG-004-002 FG-004-003 FG-004-014 FG-004-016 FG-004-018 FG-004-035 FG-004-037 FG-004-039
About this record

Access comprehensive regulatory information for NeuroVasc Technologies Envi™-SR Retriever for Mechanical Thrombectomy in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0506166 and owned by NeuroVasc Technologies, Inc.. The device was registered on September 13, 2021.

This page provides complete registration details including product owner information, registrant details, 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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