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MAQUET SERVO-U Ventilator System - HSA Registration DE0017395

Access comprehensive regulatory information for MAQUET SERVO-U 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 DE0017395 and owned by Maquet Critical Care AB. The device was registered on August 12, 2015.

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
DE0017395
MAQUET SERVO-U Ventilator System
HSA Registration Number: DE0017395
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Product Description

MAQUET SERVO-U Ventilator System is intended for respiratory support, monitoring and treatment of neonatal, pediatric and adult patients. The use of Servo-u Ventilator System is indicated when the patientโ€™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.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Anaesthesiology
Registration Information
Registration Number
DE0017395
Registration Date
August 12, 2015
Change Notification Approval Date
February 11, 2025
Retention Due Date
August 11, 2025
Product Owner
Short Name
Maquet Critical Care AB
Address
Rontgenvagen 2, Solna, SE, 171 54, SWEDEN
Registrant
Address
20 BENDEMEER ROAD, #06-01/02, SINGAPORE 339914
Importer
Address
20 BENDEMEER ROAD, CyberHub Building, #06-02, SINGAPORE 339914 20 BENDEMEER ROAD, #06-01/02, SINGAPORE 339914
Model Information
Model Name(s)
CO2 airway adapter, neonatal (reusable) CO2 airway adapter, adult (reusable) Test Lung 190 Clamp, rail 10x 25 mm Test Lung 191 Neonatal Servo Humidifier 161 Servo Humidifier 162 Servo Humidifier 163 Servo Filter Humidifier 172 Servo Filter Humidifier 173 Support arm 177 Compressor Mini 230V 50/ 60 Hz Battery Module, SERVO Ventilator Test tube, grey Data cable SERVO ventilator to PC, 2.4 m Fisher & Paykel cable for disposable dual heated circuit Stand-alone mounting kit for Compressor Mini Servo Guard viral/ bacterial filter, 50 pcs/ pkg O2 cell for exchange on installed SERVO ventilators Aeroneb Pro adult T-adapter with plug, 5 pcs/pkg Aeroneb Pro pediatric T-adapter with plug, 5pcs/ pkg Aeroneb Pro neonatal adapter kit, 5 pcs/pkg Aeroneb Pro nebulizer unit with filter cap Aeroneb Pro Filler Cap, 5 pcs/pkg Aeroneb Pro Silicon rubber plug for T-adapter, 5 pcs/pkg O2-cell, new SERVO ventilator Mains power cable, 3.5 m, Great Brtian, UK BS 1363 O2 sensor, on-site upgrade O2 sensor, new SERVO ventilator Hose, Air, NIST female/female (black/white) 1,5m Hose, Air, NIST female/female (black/white) 5m Hose, Air, NIST male/female (black/white), 5 m Country kit, Compressor Mini, English, NIST, kPa, European Hose, Air, NIST male/ female (black/white), 3 m Hose, O2, NIST female/female (white), 3 m Hose, O2, NIST female/female (white), 5 m Guide Wire for Edi catheter, 6 Fr, neonatal, 49 + 50 cm, 5 pcs/pkg Guide Wire for Edi catheter, 8 Fr, pediatric, 100 cm, 5 pcs/pkg Guide Wire for Edi catheter, 8 Fr, adult 125 cm, 5pcs/pkg Servo Duo Guard Edi Module SERVO Ventilator, 50Hz Edi Module SERVO Ventilator, 60Hz Aeroneb Solo Nebulizers, 5pcs/ pkg Aeroneb Solo Nebulizers, 10pcs/pkg Aeroneb Solo adult T-adapter, disposable, 10 pcs/ pkg Aeroneb Solo Paediatric T-adapter, disposable, 10pcs/pkg Aeroneb Solo Pediatric T-adapter and Neonatal Adapter Kit, disposable, 10 pcs/pkg Aeroneb Solo Neonatal T'-adapter, disposable, 12 mm male/female, 10 pcs/pkg Aeroneb Solo silicone rubber plug for T-adapter, 10 pcs/pkg Aeroneb Solo convenience pack, 5pcs/pkg Aeroneb Solo convenience pack,10pcs/pkg CO2 airway adapter, neonatal (disposable), 10 pcs/pkg CO2 airway adapter, adult (disposable), 10 pcs/pkg Miniflow adapter, disposable, 20 pcs/pkg Mask neonatal, disposable, Size S, 10 pcs/pkg Mask neonatal, disposable, Size M, 10 pcs/pkg Mask neonatal, disposable, Size L, 10 pcs/pkg Prong, disposable, Size XS, 10 pcs/pkg Prong, disposable, Size S, 10 pcs/pkg Prong, disposable, Size M, 10 pcs/pkg Prong, disposable, Size L, 10 pcs/pkg Prong, disposable, Size XL, 10 pcs/pkg Prong, disposable, Size L-wide, 10 pcs/pkg BONET XS for use with Medijet or Miniflow Single use bonnet (small) for use with Medijet or Miniflow Single use bonnet (medium) for use with Medijet or Miniflow Single use bonnet (large) for use with Medijet or Miniflow Single use bonnet (x large) for use with Medijet or Miniflow Single use bonnet (xx large) for use with Medijet or Miniflow Single use bonnet (xxx large) for use with Medijet or Miniflow Strip for disposable bonnet, Size XXS/XS (13 cm), 10 pcs Strip for disposable bonnet, Size S/M (15 cm), 10 pcs Strip for disposable bonnet, Size L/XL (18 cm), 10 pcs Strip for disposable bonnet, Size XXL/ XXXL (20 cm),10 pcs MINIFLOW starter Kit small 10 patients MINIFLOW starter kit large 20 patients Aeroneb Continuous Nebulization syringe, 5 pcs/ pkg Aeroneb continuous Nebulization tube set, 5 pcs/ pkg Mask neonatal, disposable, Size XL, 10 pcs/pkg Breathing system 22 mm (for HME), Disposable 1.5 m Insp. Limb Breathing system 15 mm (for HME), Disposable 1.2 m Insp. Limb Breathing system 22 mm (Active Humid.), Hytrel Reusable 1.5m Insp. Limb Breathing system 22 mm (Active Humid.), Silicone Reusable 1.5m Insp. Limb Breathing system 22 mm (HME) Hytrel Reusable 1.5 m Insp. Limb Breathing system 22 mm (HME) Silicone Reusable 1.5 m Insp. Limb Non Invasive Ventilation Face Mask, Reusable Size S Non Invasive Ventilation Face Mask, Reusable Size M Non Invasive Ventilation Face mask, Reusable Size L Non Invasive Ventilation Face Mask, Disposable Size S Non Invasive Ventilation Face Mask, Disposable Size M Non Invasive Ventilation Face Mask, Disposable Size L Breathing system 15 mm (HME) Hytrel Reusable 1.5 m Insp. Limb Breathing system 10 mm (HME) Hytrel Reusable 1.5 m Insp. Limb Breathing system 15 mm (Active Humid.), Hytrel Reusable 1.5m Insp. Limb Breathing system 10 mm (Active Humid.), Hytrel Reusable 1.5m Insp. Limb Breathing system 10 mm (for HME), Disposable 1.2 m Insp. Limb Breathing system 10 mm (Active Humid.), Silicone Reusable 1.5m Insp. Limb 1.5 m, Silicone Breathing system 22 mm (Active Humid.), Disposable 2.1m Insp. Limb Breathing system 10 mm (Active Humid.), Disposable 2.2m Insp. Limb Patient tube 10mm, 30 cm Hytrel, 5 pcs Flextube Hytrel 15 mm Hytrel Handle, SERVO-U, upgrade Mounting kit for Compressor Mini on Mobile Cart SERVO-U/ SERVO-N SERVO-U country kit, English, NIST, European Y Sensor Module, SERVO-U, SERVO-N Y Sensor Neonatal Disposable SERVO-U, SERVO-N Y Sensor neonatal, reusable Y Sensor Pressure Line, 1.8 m, disposable, 10 pcs/ pkg Mobile Cart SERVO-U/ SERVO-N without drawers, flat pack Drawer for Mobile Cart, SERVO-U/ SERVO-N Pendant/ bed holder, SERVO-U/ SERVO-N Shelf Base, SERVO-U/ SERVO-N Support Arm 178 Gas cylinder restrainer kit, SERVO-U/ SERVO-N Waterbag/ IV Pole SERVO-U/ SERVO-N Humidifier Holder SERVO-U/ SERVO-N Breathing System 22 mm (Dual Heated.), Disposable 1.5m Inps. Limb Breathing system for dual heated active humidification 10 mm, insp. Limb 2 m, disposable, 10 pcs/pkg Cable holder SERVO-U/ SERVO-N Expiratory cassette, SERVO-U Base unit SERVO-U Breathing system 22 mm (heater humidifier), insp. Limb 1.6 m, Silicone Breathing system 10 mm (Heater humidifier), insp. Limb 1.6 m, Silicone Prong, disposable, Size M-wide, 10 pcs/pkg Starter kit ventilation pediatric, 15 mm (for passive humidification) Starter Kit Ventilation With HME Adult User Interface holder, SERVO-U/ SERVO-N Telefrelx Neptune adapter for Humidifier Holder CO2/ Y sensor adpater, 10 pcs/pkg Handle, new SERVO-U Y-piece 10 mm angled, sampling port, 5 pcs/pkg Starter kit ventilation neonatal, 10 mm (for active humidification) Upgrade via E-delivery, SERVO-U Y piece holder and hook, SERVO-U/ SERVO-N Thermoshell, Expiratory cassette SERVO-U/ SERVO-N, 5 pcs/ pkg Capnostat 5 mainstream CO2 sensor Base software Servo-u Base SW Servo-u Adult CO2 analyzer module Capnostat 5, Servo ventilators Heliox Servo adapter kit, NIST/NIST Heliox Servo adapter kit, AGA/NIST Heliox Servo adapter kit, DISS NIV adapter for HFO circuit Water trap for HFO circuit Tube connector 22-15 mm, angled, 5 pcs/pkg Clamp, 1 slot
Model Identifier(s)
4721788 4721796 6006832 6038801 6301720 6419340 6419357 6419365 6419373 6419381 6481720 6481787 6487180 6487941 6523570 6595214 6595396 6595487 6640044 6647817 6647825 6647833 6647841 6647866 6647874 6650118 6670310 6670600 6670680 6671157 6671160 6671162 6671172 6671250 6671252 6671257 6671270 6671272 6671292 6671775 6672330 6672332 6675672 6675675 6675677 6675680 6675682 6675685 6675690 6675742 6675745 6684610 6684612 6684635 6684637 6684640 6684642 6684645 6684647 6684650 6684652 6684655 6684657 6684660 6684662 6684665 6684667 6684670 6684672 6684675 6684677 6684680 6684682 6684685 6684897 6684900 6686730 6686732 6688545 6691957 6691960 6691962 6691965 6691967 6691970 6691972 6691975 6691977 6691980 6691982 6691985 6692150 6692152 6692155 6692157 6692160 6692162 6692165 6692170 6692452 6692455 6692510 6692675 6693612 6693662 6693667 6693670 6693672 6693695 6693707 6693710 6693712 6693715 6693720 6693722 6693735 6693737 6693742 6693747 6693752 6694800 6695165 6695167 6696610 6696705 6696807 6880099 6880102 6880104 6880248 6880253 6880511 6880519 6880548 6880848 6882078 6884598 6884599 6887050 6889485 6889486 6889487 6891004 6891005 9037730 9358193