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MAQUET Servo-i ventilator systems - HSA Registration DE0008130

Access comprehensive regulatory information for MAQUET Servo-i ventilator systems in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0008130 and owned by Maquet Critical Care AB. The device was registered on December 06, 2011.

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
DE0008130
MAQUET Servo-i ventilator systems
HSA Registration Number: DE0008130
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Product Description

Ther SERVO-i Ventilator System is intended for treating and monitoring patients ranging from neonates to adults with respiratory failure or respiratory insufficiency.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Anaesthesiology
Registration Information
Registration Number
DE0008130
Registration Date
December 06, 2011
Change Notification Approval Date
July 01, 2019
Retention Due Date
December 05, 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)
Connect Hose NBP 3.7 m Sensor Capnostat III etCO2 Adap etCO2 Airway Neo Adap etCO2 Airway Adult Test Lung 190 Rail Clamp 10x25mm Humidifier Chamber Adlt Absorbent Paper Adlt F&P 100Pc. Absorbent Paper Inf F&P 100Pc. Test Lung 191 Neonatal Nipple Air Filter 6mm 2Pc. Support Arm 176 Pat Tube Silic Inf 10mm 10cm 5Pc. Servo Humidifier 161 100Pc. Servo Humidifier 162 100Pc. Servo Humidifier 163 100Pc. Servo Filter Humidifier 172 100Pc. Servo Filter Humidifier 173 100Pc. Expiratory Cassette Support Arm 177 IV Pole Compressor Mini 230V 50Hz EN Mobile Cart w/ Drawers Servo-i Battery Module, Servo-i Servo-i Base Unit Test Tube blue cO2 Analzyer Module, Servo-i Humidifier Holder SW Servo-i Adult SW Servo-i Infant Gas Cylinder Restrainer Servo-i Country Kit Servo-i NIST EN Upgrade via freight, Servo-i Gas Trolley for Mobile Cart Servo-i SW Ultra Nebulizer Servo-i SW Automode Servo-i SW Bi-Vent Servo-i SW Open Lung Tool Servo-i Ventilation Record Card SW PRVC Servo-i SW Volume Support Servo-i SW Pressure Control (PC) Servo-i SW Volume Control Servo-i SW All patient categories upgrade Humidifier holder for rail Humidifier MR850AEU 230V EN ES FR Mobile Cart SERVO I with drawers, Flat Pack Mobile Cart w/o Drawers Servo-i Kit of accessories MR850 Set tubes adult single u,single h. Set tubes infant,single u,single h Cable,single use single tube heater Water Bag Pole Temperature and flow probe MR850 Stand-alone Mounting Kit Comp Mini Servo Guard 50 Pc. Set Pat Tube Hytrel Inf 22/15 SH Set Pat Tube Hytrel Inf 22/15 F&P6- Mobile Cart for Comp Mini Servo-i Drawer Kit for Mobile Cart Servo-i Humidifier MR850AEK 230V EN Adult T-adapter with plug,5 each Pediatric T-adapter with plug,5each Neonate Adapter Kit 5 each Nebulizer unit Filler Cap,5 each Siliconplugg,5 each Isolator shield w drip guard, 5 ea Alarm output conn. kit (s/n >10000) SW Alarm output connector Servo-i Upgrade via E-delivery, Servo-i O2-cell SERVO-i/-s Boosterkit SW NIV Servo-i Software download card Holder for Aeroneb Y Sensor Module Y Sensor Adult (10 pcs) Y Sensor Infant (10 pcs) O2 Sensor SW SERVO-i Universal Basic edition SW Nasal CPAP, Servo-i SW Y-sensor SW SERVO-i Universal Extended edition Interhospital transport kit NIST/NIST Air Hose, 1,5m NIST/NIST Air Hose, 5m NIST/NIST Air Hose, 5m Country kit Comp Mini EN NIST NIST/NIST Air Hose, 3m NIST/NIST O2 Hose, 3m NIST/NIST O2 Hose, 5m Guide Wire for Cath. 6671277, 5each Guide Wire for Cath. 6671280, 5each Guide Wire for Cath. 6671282, 5each Servo-i Holder SERVO-I Shelf base T-adapter, F&P circ (neo), 5 ea Servo Duo Guard 60 Pcs. NAVA software Servo-i MR Environment kit, new SERVO-i Edi Module 50Hz Servo Ultra Nebulizer Servo-i Low MV Alarm audio off SW Servo-i Heliox SW SERVO-i Heliox adapt. kit NIST, New SERVO-i High Pressure hose Heliox NIST 5m Aeroneb Solo Starter Kit - UK Aeroneb Solo Nebulizers, 5pcs Aeroneb Solo Nebulizers, 10pcs Aeroneb Solo Adult T's, 10pcs Aeroneb Solo Paediatric T's, 10pcs Aeroneb Solo Paed T's+Neo Adap, 10each Aeroneb Solo Neont. T's 12mm M/F, 10pcs Luer Con. for Cont. Neb., 10pcs Tee-piece plugs, 10pcs Aeroneb Solo Conv. pack, 5pcs Aeroneb Solo Conv. pack, 10pcs Heliox adapter kit NIST, upgrade High Pressure hose Heliox Schraeder SW NIV NAVA, Servo-i Miniflow adapter (REF 4000) Mask neonatal S, disposable, 10 pieces Mask neonatal, M, disposable, 10 pieces Mask neonatal, L, disposable 10 pieces Prongs micro/ XS (1200-01), disposable 10 pieces Prongs S (1200-21), disposable 10 pieces Prongs M (1200-02), disposable 10 pieces Prongs L (1200-22), disposable 10 pieces Prongs XL (1200-03), disposable 10 pieces Prongs L-wide (1200-33), disposable 10 pieces 10x single use bonnet (x small) for use with Medijet or Miniflow, (REF 1214-10) 10x single use bonnet (small) for use with Medijet or Miniflow, (REF 1215-10) 10x single use bonnet (medium) for use with Medijet or Miniflow, (REF 1216-10) 10x single use bonnet (large) for use with Medijet or Miniflow, (REF 1217-10) 10x single use bonnet (x large) for use with Medijet or Miniflow, (REF 1218-10) 10x single use bonnet (xx large) for use with Medijet or Miniflow, (REF 1219-10) 10x single use bonnet (xxx large) for use with Medijet or Miniflow, (REF 1220-10) 5 pairs of single use of strips (15 cm) for use with bonnet 1213-10 or 1214-10 (REF 1212-13) 5 pairs of single use of strips (15 cm) for use with bonnet 1215-10 or 1216-10 (REF 1212-15) 5 pairs of single use of strips (18 cm) for use with bonnet 1217-10 or 1218-10 (REF 1212-18) 5 pairs of single use of strips (20 cm) for use with bonnet 1219-10 or 1220-10 (REF 1212-20) Miniflow starter kit small (10 patients) (REF 4000-10) Miniflow starter kit small (20 patients) (REF 4000-20) Aeroneb Module, Servo-i Aeroneb Module Pro Kit, Servo-i Aeroneb Module Solo Kit, Servo-i Edi Catheter, 6fr, 49cm, 5 each, PHT free, 5 pcs/ pkg Edi Catheter, 6fr, 50cm, 5 each, PHT free, 5 pcs/ pkg Edi Catheter, 8fr, 100cm, 5 each, PHT free, 5 pcs/ pkg Edi Catheter, 8Fr, 125cm, 5 each, PHT free, 5 pcs/ pkg Edi Catheter, 12Fr, 125cm, 5 each, PHT free, 5 pcs/ pkg Edi Catheter, 16Fr, 125cm, 5 each, PHT free, 5 pcs/ pkg Aeroneb Module Control Cable Breathing System 22 mm (for HME) Disposable 1.5M Insp. Limb Breathing System 15 mm (for HME) Disposable 1,2M 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 1.5m Insp. Limb Breathing System 22 mm (HME) Silicone Reusable 1.5m 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 1.5m Insp. Limb Breathing System 10 mm (HME) Hytrel Reusable 1.5m 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, 1.2M Insp. Limb Breathing System 10mm (Active Humid) Silicone Reusable 1.5m Insp. Limb Breathing System 22 mm (Active Humid) Disposable 1.7m Insp. Limb Breathing System 10 mm (Active Humid) Disposable 1.7m Insp. Limb Breathing System 15 mm (for HME and MR) Disposable 3.0M Insp. Limb Breathing System 10 mm (for HME and MR) Disposable 3.0M Insp. Limb Breathing System 22 mm (for HME and MR) Disposable 3.0M Insp. Limb set of breathing circuit anesthesia, 22mm Disposable, 1.5M Insp. Limb Set of breathing circuit anesthesia, 15mm Disposable, 1.2M Insp. Limb Set of breathing circuit anesthesia, 10mm Disposable, 1.2M Insp. Limb Gas Sampling Line, 2.0M (M/M Connectors) Breathing Bag Anesthesia, Disposable, Size 0.5L Breathing Bag Anesthesia, Disposable, Size 1L Breathing Bag Anesthesia, Disposable, Size 2L Breathing Bag Anesthesia, Disposable, Size 3L Anesthesia mask reusable, Size 0 small infant Anesthesia mask reusable, Size 1, medium infant Anesthesia mask reusable, Size 2, large infant Anesthesia mask reusable, Size 3, small adult Anesthesia mask reusable, Size 4, medium adult Anesthesia mask reusable, Size 5, large adult Anesthesia mask, disposable, small adult, size 3 Anesthesia mask, disposable, medium adult, size 4 Anesthesia mask, disposable, large adult, size 5 Anesthesia mask, disposable, extra large, size 6 Patient tube Hytrel 10 mm , 30cm, 5 pieces Flextube Hytrel 15 mm, 15cm, 1 piece New Capnostat 5 mainstream CO2 Sensor Set Pat Tube Silic Adlt Servo Hum Set Pat Tube Silic Inf 10 Servo Hum Angled Adapter 22-15mm/15mm 5Pc. Air Filter w/ Mount Br w/o Nipple Humidifier Chamber Inf Set Pat Tube Hytrel Adlt Servo Hum Set Pat Tube Hytrel Inf 10 Servo H Clamp 1 Slot Hook w/ Hook Holder Set Pat Tube Silic Inf 10 F&P6/7 Set Pat Tube Hytrel Inf 10 F&P6/7 Set Pat Tube Silic Adlt F&P600/730 Set Pat Tube Hytrel Adlt F&P600/730
Model Identifier(s)
1275275 4322975 4721788 4721796 6006832 6038801 6150754 6150762 6150804 6301720 6350990 6405976 6406909 6419340 6419357 6419365 6419373 6419381 6447960 6481720 6481738 6481787 6486729 6487180 6487800 6487941 6523588 6523935 6524214 6524222 6524339 6524396 6532639 6532910 6533033 6533140 6533157 6533173 6533181 6533744 6533751 6533769 6533785 6533793 6545110 6545185 6568146 6594845 6595057 6595081 6595107 6595206 6595230 6595255 6595396 6595487 6606128 6606136 6632603 6632611 6647528 6647817 6647825 6647833 6647841 6647866 6647874 6647890 6649730 6649748 6650100 6650118 6666593 6667187 6667245 6670212 6670650 6670660 6670662 6670680 6670802 6670805 6670807 6670980 6670992 6671157 6671160 6671162 6671172 6671250 6671252 6671257 6671270 6671272 6671292 6671717 6671720 6671767 6671775 6671965 6672287 6672330 6672735 6675577 6675580 6675582 6675607 6675657 6675672 6675675 6675677 6675680 6675682 6675685 6675687 6675690 6675742 6675745 6677555 6681252 6683412 6684635 6684637 6684640 6684642 6684645 6684647 6684650 6684652 6684655 6684657 6684660 6684662 6684665 6684667 6684670 6684672 6684675 6684677 6684680 6684682 6684685 6684897 6684900 6685342 6685345 6685347 6685775 6685777 6685780 6685782 6685787 6685790 6687685 6691957 6691960 6691962 6691965 6691967 6691970 6691972 6691975 6691977 6691980 6691982 6691985 6692150 6692152 6692155 6692157 6692160 6692162 6692165 6692170 6692172 6692175 6692177 6692205 6692207 6692210 6692212 6692215 6692217 6692220 6692222 6692225 6692227 6692230 6692232 6692235 6692237 6692240 6692242 6692245 6692247 6692452 6692455 6882078 9020561 9020579 9037730 9085556 9154295 9318056 9318064 9358193 9368952 9380502 9380510 9381484 9381492