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Lutronic enCurve Short-wave therapy equipment - HSA Registration DE0501473

Access comprehensive regulatory information for Lutronic enCurve Short-wave therapy equipment in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0501473 and owned by Lutronic Corporation. The device was registered on April 04, 2018.

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
DE0501473
Lutronic enCurve Short-wave therapy equipment
HSA Registration Number: DE0501473
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Product Description

Lutronic enCurve Short-wave therapy equipment is indicated for pain relief in patients with knee osteoarthritis.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0501473
Registration Date
April 04, 2018
Change Notification Approval Date
January 23, 2024
Retention Due Date
April 03, 2026
Product Owner
Short Name
Lutronic Corporation
Address
Lutronic Center, 219 Sowon-ro, Deogyang-gu, Goyang-si, Gyeonggi-do, KOREA, REPUBLIC OF
Registrant
Address
19 KIM KEAT ROAD, FU TSU BUILDING, #06-01, SINGAPORE 328804
Importer
Address
50 UBI AVENUE 3, FRONTIER, #05-09, SINGAPORE 408866
Model Information
Model Name(s)
Encurve Multi Applicator AB Applicator
Model Identifier(s)
1100300600 6100317001 6100317002