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Singapore HSA registration DE0510051

HIWIN Robotic Gait Training System MRG-P100

Singapore flagSingapore·CLASS B·HIWIN TECHNOLOGIES CORPORATION·Registered November 18, 2024
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0510051
Registration Date
November 18, 2024
Retention Due Date
November 17, 2025
Product description
The MRG-P100 is used for patients who have walking difficulty to improve lower limb muscle strength and walking ability. Indications for use The MRG-P100 can be used for patients with spinal cord injury, stroke, traumatic brain injury, multiple sclerosis, Parkinson's disease, muscular dystrophy, walking difficulty caused by neuropathy or advanced age to improve the limb action and physical ability.
Product Owner
Name
HIWIN TECHNOLOGIES CORPORATION
Short Name
HIWIN TECHNOLOGIES CORPORATION
Address
No.13 Jingke 8th Rd, Nantun Dist,, Taichung City 40852, TAIWAN
Registrant
Name
BMEC PTE LTD
Address
82 UBI AVENUE 4, EDWARD BOUSTEAD CENTRE, #08-01, SINGAPORE 408832
Importer
Name
BMEC PTE LTD
Address
82 UBI AVENUE 4, EDWARD BOUSTEAD CENTRE, #08-01, SINGAPORE 408832
Model information
Model Name(s)
Emergency stop button Monitor IPC Remote control (power rise assistance) Remote control (exoskeleton) AC motor Actuator AC motor Power rise assistance Wireless mouse Robotic Gait Training System
Model Identifier(s)
46230072 4CD00411 4CD00451 4D01002L 4D0100C8 4D53003P 4D530044 4D53004B 4D800043 5017I0J3 MRG-P100
About this record

Access comprehensive regulatory information for HIWIN Robotic Gait Training System MRG-P100 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510051 and owned by HIWIN TECHNOLOGIES CORPORATION. The device was registered on November 18, 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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B