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Mekics OmniOx HFT700 Portable Ventilator - HSA Registration DE0509091

Access comprehensive regulatory information for Mekics OmniOx HFT700 Portable Ventilator in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0509091 and owned by MEKICS CO., LTD. The device was registered on March 22, 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 C
DE0509091
Mekics OmniOx HFT700 Portable Ventilator
HSA Registration Number: DE0509091
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Product Description

The HFT 700 is for assist-ventilation and is intended to augment the spontaneous ventilation. It is not intended to provide the mandatory ventilation requirements of the patient (>3kg for HF mode, > 20kg for CPAP and BiPAP mode). This is a device for ventilation in ICU, Ward and Home.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0509091
Registration Date
March 22, 2024
Retention Due Date
March 21, 2026
Product Owner
Short Name
MEKICS CO., LTD
Address
21, Sangjiseok-gil, Paju-si, Gyeonggi-do, 10911, KOREA, REPUBLIC OF
Registrant
Address
7030 ANG MO KIO AVENUE 5, NORTHSTAR @ AMK, #04-20, SINGAPORE 569880
Importer
Address
7030 ANG MO KIO AVENUE 5, NORTHSTAR @ AMK, #04-20, SINGAPORE 569880
Model Information
Model Name(s)
OmniOx HFT700 OmniOx HFT700 + MPS100(External Power Supply)
Model Identifier(s)
MH0012_00 MH0012_02