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MAQUET SERVO-N Ventilator System - HSA Registration DE0017396

Access comprehensive regulatory information for MAQUET SERVO-N 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 DE0017396 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
DE0017396
MAQUET SERVO-N Ventilator System
HSA Registration Number: DE0017396
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Product Description

MAQUET SERVO-N Ventilator System is intended for respiratory support, monitoring and treatment of neonatal and pediatric patients.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Anaesthesiology
HSA Product Code
Refer to CRPNS
HS Code
90192000
Registration Information
Registration Number
DE0017396
Registration Date
August 12, 2015
Change Notification Approval Date
January 06, 2023
Retention Due Date
August 11, 2025
Product Owner
Short Name
Maquet
Address
Rontgenvagen 2, Solna, SE, 17195, 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) Clamp, rail 10 x 25 mm Test Lung 191, Neonatal Servo Humidifier 161 Servo Humidifier 162 Compressor Mini 230V, 50/60 Hz Battery Module, SERVO Ventilator Test Tube, grey Data cable SERVO ventilator to PC, 2.4m Fisher & Paykel cable for disposable dual heated circuit Stand-alone mounting kit for Compressor Mini Servo Guard viral/ bacterial filter, 50 pcs / pkg Aeroneb Pro neonatal T-adapter, with plug, 12 mm male/female, 5 pcs/pkg O2 cell for exchange on installed SERVO ventilators Aeroneb Pro pediatric T-adapter with plug, 5 pcs/ pkg Aeroneb Pro neonatal adapter kit, 5 pcs/pkg Aeroneb Pro Nebulizer unit with filler 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 Britain, UK BS 1363 O2 sensor, on-site ugrade O2 Sensor, new SERVO Ventilator Hose, Air, NIST female/female (black/white), 1.5 m Hose, Air, NIST female/ female (black/white), 5 m 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 Servo Duo Guard Edi Module, SERVO Ventilator, 50 Hz Edi Module, SERVO ventilator, 60 Hz Aeroneb Solo Nebulizers, 5 pcs/pkg Aeroneb Solo Nebulizers, 10 pcs/ pkg Aeroneb Solo pediatric T-adapter, disposable, 10 pcs/ 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 CO2 airway adapter, neonatal (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 Bonnet, disposable, Size XS, 10 pcs/pkg Bonnet, disposable, Size S, 10 pcs/pkg Bonnet, disposable, Size M, 10 pcs/pkg Bonnet, disposable, Size L, 10 pcs/pkg Bonnet, disposable, Size XL, 10 pcs/pkg Bonnet, disposable, Size XXL, 10 pcs/pkg Bonnet, disposable, Size XXXL, 10 pcs/pkg 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 Base unit SERVO-N Handle, new SERVO-N upgrade Breathing system 15 mm (for HME), Disposable 1.2 m Insp. Limb Non Invasive Ventilation Face Mask, Reusable Size S Non Invasive Ventilation Face Mask, Disposable Size S Breathing system for HME, 15 mm Hytrel (1.5 m) Breathing system 10 mm (HME) Hytrel Reusable 1.5 m Insp. Limb Breathing system 15 mm for single heated active humidification, insp. limb 1.5 m, Hytrel Breathing system 10 mm for single heated active humidification, insp. limb 1.5 m, Hytrel 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 for single heated active humidification 10 mm, insp. limb 2.2 m disposable, 10 pcs/pkg Patient tube 10mm, 30 cm Hytrel, 5 pcs Flex tube 15 mm Hytrel Mounting Kit for compressor Mini on Mobile Cart SERVO-U/ SERVO-N SERVO-N 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 Water Bag / IV pole SERVO-U/ SERVO-N Humidifier Holder SERVO-U/ SERVO-N 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-N 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) User interface holder, SERVO-U/ SERVO-N Telefex Neptune adapter for Humidifier Holder CO2/ Y sensor adaptor, 10 pcs/pkg Handle, new SERVO-N Y-piece 10 mm angled, sampling port, 5 pcs/pkg Starter kit ventilation neonatal, 10 mm (for active humidification) Upgrade via E-delivery, SERVO-N Sticker "Ladybug", new SERVO-N sticker "Ladybug", new SERVO-N Y piece holder and hook, SERVO-U/ SERVO-N Sticker "Ladybug", on-site upgrade Thermoshell, Expiratory cassette SERVO-U/ SERVO-N, 5 pcs/ pkg Capnostat 5 mainstream CO2 sensor CO2 analyzer module Capnostat 5, Servo ventilators Clamp 1 Slot
Model Identifier(s)
4721788 6038801 6301720 6419340 6419357 6481787 6487180 6487941 6523570 6595214 6595396 6595487 6617767 6640044 6647825 6647833 6647841 6647866 6647874 6650118 6670310 6670600 6670680 6671157 6671160 6671162 6671172 6671250 6671252 6671257 6671270 6671272 6671775 6672330 6672332 6675672 6675675 6675680 6675682 6675685 6675690 6684610 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 6688600 6690937 6691960 6691972 6691980 6692150 6692152 6692155 6692157 6692160 6692162 6692170 6692452 6692455 6692675 6693567 6693662 6693667 6693670 6693672 6693695 6693707 6693710 6693712 6693715 6693720 6693722 6693735 6693742 6693747 6693750 6695167 6696610 6696705 6880099 6880102 6880104 6880247 6880253 6880511 6880538 6880543 6880548 6880794 6880848 6882078 6887050 9358193