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Sign in to claim this brandMaquet Critica Care AB
Sweden·SE-MF-000001264
Last updated May 23, 2026
What Maquet Critica Care AB makes
Maquet Critica Care AB manufactures the Servo-air 4.0 Ventilator System, a mechanical ventilator designed for respiratory support in clinical settings.
The Servo-air 4.0 Ventilator System is classified as a Class II medical device and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Maquet Critica Care AB manufacture?
Maquet Critica Care AB specializes in mechanical ventilators. Their primary product, the Servo-air 4.0 Ventilator System, is designed to provide respiratory support in clinical environments. This device is intended for patients requiring assisted or controlled ventilation, such as those in intensive care or recovery settings.
Where is Maquet Critica Care AB based, and how does this affect its regulatory oversight?
Maquet Critica Care AB is based in the United States. Since the company operates within the U.S., its devices are subject to regulatory oversight by the FDA. The Servo-air 4.0 Ventilator System, for example, is classified under the FDA’s 510(k) pathway, meaning it must demonstrate substantial equivalence to a legally marketed predicate device to enter the market.
Which regulatory registries or databases list Maquet Critica Care AB’s devices?
The Servo-air 4.0 Ventilator System is listed under the FDA’s 510(k) pathway, indicating it has undergone the required premarket notification process. This means the device is documented in the FDA’s 510(k) registry, which tracks medical devices that have been cleared through this pathway. This registry serves as a public record of devices authorised for sale in the U.S.
How are Maquet Critica Care AB’s devices classified under medical device regulations?
The Servo-air 4.0 Ventilator System is classified as a Class II medical device. This classification is determined by the FDA based on the device’s intended use and potential risk. Class II devices generally require special controls in addition to general controls to ensure their safety and effectiveness, such as performance standards or post-market surveillance. The classification influences the regulatory pathway the device must follow before being authorised for market.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Sweden
- Address
- 2, Röntgenvägen , Solna, Sweden
- Website
- getinge.com
- —
- —
- [email protected]
- Phone
- +46 10 335 73 00
- PRRC Contact
- —
- EUDAMED SRN
- SE-MF-000001264
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (248)
Page 4 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Water Trap Dryline A KMG2000 10each | 6522747 | FDA UDI | Class II | Active |
| Y Sensor Pressure Line | 6693672 | FDA UDI | Class II | Active |
| Support arm 179 | 6882001 | FDA UDI | Class II | Active |
| Cable Holder | 6693747 | FDA UDI | Class II | Active |
| Capnostat 5 | 6882078 | FDA UDI | Class II | Active |
| Breath circuit 22 disp 1.5m | 6694597 | EUDAMEDFDA UDI | Class I | Active |
| Starter Kit Anesthesia, Infant | 6696712 | FDA UDI | Class I | Unknown |
| Mobile Cart, Flat Pack Servo-air | 6881999 | FDA UDI | Class II | Active |
| Breath syst 22mm Act Disp2.1m 10pcs | 6692165 | FDA UDI | Class I | Unknown |
| NIV Mask (L) reuse, 2 ports, MAQUET | 6694587 | FDA UDI | Class I | Unknown |
| Edi Catheter ENFit 6Fr/49 cm, 5pcs | 6883898 | FDA UDI | Class II | Active |
| Gas sampling line 2.0m (M/M) | 6693510 | FDA UDI | Class II | Active |
| Vaporizer Sevoflurane, MAQUET filling | 6886601 | FDA UDI | Class II | Active |
| Humidifier Holder | 6523935 | FDA UDI | Class II | Active |
| Dustfilter 40pcs Reus.Abso.Flow-i | 6880430 | FDA UDI | Class I | Active |
| Cable Suport Arm | 6687487 | FDA UDI | Class II | Active |
| Starter Kit Anesthesia, Adult | 6696810 | FDA UDI | Class I | Unknown |
| Cover for vaporizer slot | 6880158 | FDA UDI | Class II | Active |
| Vaporizer Sevoflur. Maquet filling | 6682282 | FDA UDI | Class II | Active |
| Flextub Hytrel 15mm 15cm | 6692455 | FDA UDI | Class I | Active |
| Support Arm 178 | 6693715 | FDA UDI | Class II | Active |
| CO2 analyzer module, SERVO vent | 6523588 | FDA UDI | Class II | Active |
| Breath bag set Anest 22mm Hytrel | 6692187 | FDA UDI | Class I | Active |
| Battery Module | 6487180 | FDA UDI | Class II | Active |
| Volume reflector assy PPSU | 6695835 | FDA UDI | Class II | Active |
| Breath syst 10mm Heater Humidif.Si | 6695167 | FDA UDI | Class I | Unknown |
| Breathing system 15mm HME Disp 1.2m | 6693507 | FDA UDI | Class I | Active |
| Edi Catheter ENFit 12Fr/125 cm, 5pcs | 6883903 | EUDAMEDFDA UDI | Class II | Active |
| Universal Holder assy | 6880068 | FDA UDI | Class II | Active |
| Reusable Absorber | 6692582 | FDA UDI | Class I | Active |
| Edi Catheter ENFit 8Fr/50 cm, 5pcs | 6883900 | EUDAMEDFDA UDI | Class II | Active |
| Y Sensor Module | 6670650 | FDA UDI | Class II | Active |
| Gas Cylinder Restrainer Kit | 6693720 | FDA UDI | Class II | Active |
| IV Pole | 6481738 | FDA UDI | Class II | Active |
| Dust filter 20 pcs/pkg | 6883441 | FDA UDI | Class II | Active |
| Suction tip holder | 6887714 | FDA UDI | Class II | Active |
| Adjustable arm for param. modules | 6676960 | FDA UDI | Class II | Active |
| Sampling Line 2, 5m 25Pc | 6522770 | FDA UDI | Class II | Active |
| Edi Module 60Hz | 6672332 | FDA UDI | Class II | Active |
| Edi Cath. 16Fr/125cm 1/pkg | 6686412 | FDA UDI | Class II | Active |
| Cart SERVO-i, Comp Mini, Flatpack | 6682725 | FDA UDI | Class II | Active |
| Breath bag set Anest 10mm Hytrel | 6692190 | FDA UDI | Class I | Active |
| Starter Kit Ventilation, Adult | 6696807 | FDA UDI | Class I | Unknown |
| Breath circuit 10 disp 1.2m | 6694602 | FDA UDI | Class I | Active |
| Heliox Servo adapter kit | 6889487 | FDA UDI | Class II | Active |
| Shelf base, Servo-air | 6882002 | FDA UDI | Class II | Active |
| Clamp 1 Slot | 9358193 | FDA UDI | Class II | Active |
| Carrier SERVO-i, Robust, mounted | 6672285 | FDA UDI | Class II | Active |
| Y Sensor Adult (10 pcs) | 6670660 | FDA UDI | Class II | Active |
| Pulsiocare | 6891100 | EUDAMED | Class IIb | Active |
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