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Curative GA Ventilator - HSA Registration DE0505416

Access comprehensive regulatory information for Curative GA 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 DE0505416 and owned by Curative Medical Technology Inc. The device was registered on January 29, 2021.

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
DE0505416
Curative GA Ventilator
HSA Registration Number: DE0505416
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Product Description

The GA non-invasive ventilator is an assist ventilator and is intended to augment patient breathing. It is intended solely for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician. The ventilator is intended to support patients weighing 20 kg (44 lb) or greater. The ventilator is intended to be used by qualified medical professionals, such as physicians, nurses, and respiratory therapists. The ventilator is intended to be used only with various combinations of Curative-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Anaesthesiology
Registration Information
Registration Number
DE0505416
Registration Date
January 29, 2021
Retention Due Date
January 28, 2026
Product Owner
Short Name
Curative Medical Technology Inc
Address
No. 9, PeiYuan Road, New District, 215163 Suzhou, CHINA
Registrant
Address
3 TUAS AVENUE 2, SINGAPORE 639443
Importer
Address
11 LORONG 3 TOA PAYOH, JACKSON SQUARE, #01-13, SINGAPORE 319579 11 LORONG 3 TOA PAYOH, JACKSON SQUARE, #01-13, SINGAPORE 319579 3 TUAS AVENUE 2, SINGAPORE 639443
Model Information
Model Name(s)
GA ST40P Low Flow O2 Connector Lithium Ion Rechargeable Battery for Curative GA Ventilator Power Cord GA Trolley Pressure Sampling Tube Filter Flexo Straight Connector Flexo Clip
Model Identifier(s)
29021310 CL000490-03/00 CL000495/00 CL000593-05/00 SA002006-10/00 SA002021-02 WB000462/00 WB002020 WB002022