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OMRON Electronic Nerve Stimulator HV-F311 - HSA Registration DE0508365

Access comprehensive regulatory information for OMRON Electronic Nerve Stimulator HV-F311 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508365 and owned by OMRON HEALTHCARE Co., Ltd. The device was registered on August 08, 2023.

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
DE0508365
OMRON Electronic Nerve Stimulator HV-F311
HSA Registration Number: DE0508365
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Product Description

OMRON Electronic Nerve Stimulator is intended for reducing and relieving muscle, nerve and joint pain, stiffness, fatigue and numbness in the back, arms, legs, shoulders and feet by applying electrical nerve stimulation to the surface of the skin near the site of the pain. The Electronic Nerve Stimulator offers both heat and relieves pain using TENS technology. It should be applied to normal, healthy, dry, and clean skin of adult patients.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0508365
Registration Date
August 08, 2023
Retention Due Date
August 07, 2025
Product Owner
Short Name
OMRON HEALTHCARE Co., Ltd
Address
53, Kunotsubo, Terado-cho, Muko, Kyoto, 617-0002, JAPAN
Registrant
Address
438B ALEXANDRA ROAD, ALEXANDRA TECHNOPARK, #08-01/02, SINGAPORE 119968
Importer
Address
438B ALEXANDRA ROAD, ALEXANDRA TECHNOPARK, #08-01/02, SINGAPORE 119968
Model Information
Model Name(s)
AC Adapter OMRON Electronic Nerve Stimulator HV-F311 Gels
Model Identifier(s)
HHP-CM11 HV-F311 HV-PAD-3AP