Pure Global
Singapore HSA registration DE0019027

Hamilton Medical HAMILTON-MR1 Intensive care ventilator

Singapore flagSingapore·CLASS C·Hamilton Medical AG·Registered March 03, 2017
Device classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0019027
Registration Date
March 03, 2017
Change Notification Approval Date
September 05, 2024
Retention Due Date
March 02, 2026
Product description
THE HAMILTON-MR1 ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates. Intended areas of use: - In the MRI department - In the Intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room - During transfer of ventilated patients within the hospital. The HAMILTON-MR1 ventilator is classified as MR Conditional with the use of 1.5 Tesla and 3.0 Tesla static magnetic field scanners. The HAMILTON-MR1 ventilator is a medical device intended for use by qualified , trained personnel under the direction of a physician and within the limits of its stated technical specifications.
Product Owner
Name
Hamilton Medical AG
Short Name
Hamilton Medical AG
Address
Via Crusch 8, CH-7402 Bonaduz, SWITZERLAND
Registrant
Name
SOMNOTEC (S) PTE. LTD.
Address
37 UBI CRESCENT, SINGAPORE 408586
Importer
Name
MeDeus (S) Pte Ltd SOMNOTEC (S) PTE. LTD.
Address
221 HENDERSON ROAD, HENDERSON BUILDING, #08-12, SINGAPORE 159557 37 UBI CRESCENT, SINGAPORE 408586
Model information
Model Name(s)
HAMILTON-MR1 HAMILTON-MR1 Expiratory Valve set adult/paediatric, single patient use, box of 10 Breathing set,coaxial incl flow sensor and elbow adapters, and expiratory valve, length 1.8m box of 20 Breathing set,coaxial incl flow sensor and elbow adapters, and expiratory valve, length 3.0m box of 10 Breathing set,coaxial incl flow sensor and elbow adapters, and expiratory valve, length 4.8m box of 8
Model Identifier(s)
161010 1610100 161186 260128 260167 260168
About this record

Access comprehensive regulatory information for Hamilton Medical HAMILTON-MR1 Intensive care 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 DE0019027 and owned by Hamilton Medical AG. The device was registered on March 03, 2017.

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 C