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PMT Cortac® Cortical Surface Electrode (Platinum) - HSA Registration DE0503317

Access comprehensive regulatory information for PMT Cortac® Cortical Surface Electrode (Platinum) in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0503317 and owned by PMT Corporation. The device was registered on July 03, 2019.

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
DE0503317
PMT Cortac® Cortical Surface Electrode (Platinum)
HSA Registration Number: DE0503317
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Product Description

Indicated for the following use; to evoke potential stimulation and electrocorticography diagnostic application that are critical for determining appropriate surgical approaches to treating epilepsy patients. Only the PMT® Platinum Electrode is intended for ≤ 30days use.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Neurology
Registration Information
Registration Number
DE0503317
Registration Date
July 03, 2019
Change Notification Approval Date
October 30, 2024
Retention Due Date
July 02, 2025
Product Owner
Short Name
PMT Corporation
Address
1500 Park Road, Chanhassen, MN 55317, UNITED STATES
Registrant
Address
50 SERANGOON NORTH AVENUE 4, FIRST CENTRE, #05-14, SINGAPORE 555856
Importer
Address
3791 JALAN BUKIT MERAH, E-CENTRE @ REDHILL, #07-21, SINGAPORE 159471
Model Information
Model Name(s)
Cortac®Platinum Cortical Electrodes Cortac®Platinum Cortical Electrodes Cortac®Platinum Cortical Electrodes Cortac®Platinum Cortical Electrodes Cortac®Platinum Cortical Electrodes Cortac®Platinum Cortical Electrodes Cortac®Platinum Cortical Electrodes Cortac®Platinum Cortical Electrodes Cortac®Platinum Cortical Electrodes Cortac®Platinum Cortical Electrodes Cortac®Platinum Cortical Electrodes
Model Identifier(s)
2110-04-077 2110-04-32 2110-06-077 2110-06-32 2110-08-077 2110-08-32 2110-10-32 2110-20-32 2110-32-32 2110-48-32 2110-64-32