Pure Global
Singapore HSA registration DE0018956

Maquet SERVO-air ventilator system

Singapore flagSingapore·CLASS C·Maquet Critical Care AB·Registered February 10, 2017
Device classification
Device Class
CLASS C
Medical Speciality Area
Anaesthesiology
Registration information
Registration Number
DE0018956
Registration Date
February 10, 2017
Change Notification Approval Date
April 23, 2025
Retention Due Date
February 09, 2026
Product description
Maquet SERVO-air ventilator system is intended for respiratory support, monitoring and treatment of pediatric and adult patients. It is to be used only by healthcare providers and to be used only in professional healthcare facilities and for transport within these facilities. The use of Servo-air Ventilator System is indicated when the patient’s spontaneous ventilation is inadequate to maintain life. It is also indicated as prophylaxis for imminent collapse of other physiologic functions, or ineffective gas exchange in the lungs.
Product Owner
Name
Maquet Critical Care AB
Short Name
Maquet Critical Care AB
Address
Rontgenvagen 2, Solna, SE, 171 54, SWEDEN
Registrant
Name
GETINGE SOUTH EAST ASIA PTE. LTD.
Address
20 BENDEMEER ROAD, #06-01/02, SINGAPORE 339914
Importer
Name
GETINGE SOUTH EAST ASIA PTE. LTD.
Address
20 BENDEMEER ROAD, #06-01/02, SINGAPORE 339914
Model information
Model Name(s)
O2 cell, for exchange on installed Servo ventilators CO2 Airway adapter Adult disposable Mobile Cart drawer kit, SERVO-air Expiratory heater, SERVO Duo Guard Expiratory cassette, dark grey, Servo ventilator Thermoshell, Expiratory cassette Servo ventilator, 5 pcs/pkg Mobile Cart Fat Pack SERVO-air SERVO-air Support Arm 179 Shelf Base, SERVO-air Capnostat 5 mainstream CO2 sensor SERVO-air country kit, NIST European Air inlet Filter Battery module Dust filter 20 pcs Battery charger, SERVO ventilator Upgrade via E-delivery, SERVO-air Battery module Servo-air CO2 upgrade kit, Servo‐air (<30 000) CO2 onsite upgrade kit serial number from 30000 and above
Model Identifier(s)
6640044 6684612 6693707 6693732 6693752 6880848 6881999 6882000 6882001 6882002 6882078 6882115 6882408 6882607 6883441 6883550 6884519 6889000 6891205 6891438
About this record

Access comprehensive regulatory information for Maquet SERVO-air ventilator system in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0018956 and owned by Maquet Critical Care AB. The device was registered on February 10, 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