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WR Medical Case IV system - HSA Registration DE0509987

Access comprehensive regulatory information for WR Medical Case IV 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 DE0509987 and owned by WR Medical Electronics Co. The device was registered on October 29, 2024.

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 B
DE0509987
WR Medical Case IV system
HSA Registration Number: DE0509987
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Product Description

The CASE IV System may be used on patients with neurological diseases, especially peripheral neuropathy. The system is designed to measure and log patient responses to a series of thermal or vibratory stimuli.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0509987
Registration Date
October 29, 2024
Retention Due Date
October 28, 2025
Product Owner
Short Name
WR Medical Electronics Co
Address
1700 Gervals Avenue, Maplewood MN 55109, MN, UNITED STATES
Registrant
Address
8 BURN ROAD, TRIVEX, #08-07, SINGAPORE 369977
Importer
Address
8 BURN ROAD, TRIVEX, #08-07, SINGAPORE 369977
Model Information
Model Name(s)
Power cord, Hospital grade Power Conditioner 240VAC Case IV Headphones Thermal Stimulator Liquid Crystal Paper Instructions for Use Patient Cue device Patient Response device Case IV Type II Reservoir Power Conditioner 120VAC Set of three straps for Thermal stim USB cable WR Testworks, Neurological Testing Management Software
Model Identifier(s)
309 327 5005 5006 5019 5027 5040C 5041B 5050 5448 5491 5552 5620