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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
- Jerker Åberg
- EUDAMED SRN
- SE-MF-000001264
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (245)
Page 2 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Aeroneb Module Pro kit, SERVO-i | 6685345 | FDA UDI | Class II | Active |
| Breath bag Anest Reus 2L | 6692200 | FDA UDI | Class I | Active |
| Breathing bag anest disp 3L compl | 6694612 | FDA UDI | Class I | Active |
| High Pressure hose Heliox DISS 5m | 6675592 | FDA UDI | Class II | Active |
| Aeroneb Module, SERVO-i | 6685342 | FDA UDI | Class II | Active |
| Anesthesia mask disp, size 6 | 6694270 | FDA UDI | Class I | Unknown |
| Vaporizer Sevoflurane, QUIK FIL | 6682285 | FDA UDI | Class II | Active |
| Battery module | 6882607 | FDA UDI | Class II | Active |
| Vaporizer Desflurane, Saf-T-Fil | 6682287 | FDA UDI | Class II | Active |
| Mobile Cart | 6693695 | FDA UDI | Class II | Active |
| Co2 Analyzer Module Capnostat 5 | 6887050 | FDA UDI | Class II | Active |
| Adapter 10-15mm OD 5Pc. | 6189000 | FDA UDI | Class II | Active |
| MSync | 6881603 | FDA UDI | Class I | Active |
| Horizontal short rail DIN | 6887115 | FDA UDI | Class II | Active |
| Waterbag/Iv Pole | 6693722 | FDA UDI | Class II | Active |
| Breath bag Anest Reus 0.5L | 6692195 | FDA UDI | Class I | Active |
| etCO2 Airway adapter Adult disp. 1pcs | 6884526 | FDA UDI | Class II | Active |
| Rail Clamp 10x25mm | 6038801 | FDA UDI | Class II | Active |
| Adapter assy | 6680467 | FDA UDI | Class II | Active |
| Breath bag Anest Reus 3L | 6692202 | FDA UDI | Class I | Active |
| Starter Kit Ventilation, neonatal | 6880511 | FDA UDI | Class I | Unknown |
| Aeroneb Module control cable | 6687685 | FDA UDI | Class II | Active |
| Cart SERVO-s, flatpack | 6650506 | FDA UDI | Class II | Active |
| Servo-s Base Unit | 6640440 | FDA UDI | Class II | Active |
| High Pressure hose Heliox NIST 5m | 6675607 | FDA UDI | Class II | Active |
| Thermoshell, Exp Cassette | 6880848 | FDA UDI | Class II | Active |
| Co2 Analyzer Module | 6881766 | FDA UDI | Class II | Active |
| Breath syst 22mm (Aktive Humid)Sili | 6691965 | FDA UDI | Class I | Unknown |
| Y sensor module, SERVO-U/-n | 6693662 | FDA UDI | Class II | Active |
| Edi Cath. 12Fr/125cm 1/pkg | 6686410 | FDA UDI | Class II | Active |
| Battery module | 6889000 | FDA UDI | Class II | Active |
| Breath bag Anest Reus 1L | 6692197 | FDA UDI | Class I | Active |
| Aeroneb Control Module | 6884823 | FDA UDI | Class II | Active |
| Anest mask reuse, size 3 with MAQUET | 6694575 | EUDAMEDFDA UDI | Class I | Active |
| Breath bag set Anest 15mm Hytrel | 6692192 | FDA UDI | Class I | Active |
| Patient cassette complete | 6680325 | FDA UDI | Class II | Active |
| Anest mask reuse, size 5 with MAQUET | 6694580 | FDA UDI | Class I | Active |
| SERVO-I Shelf base | 6671720 | FDA UDI | Class II | Active |
| Gas Cylinder Restrainer Servo-i | 6524339 | FDA UDI | Class II | Active |
| Shelf Base | 6693712 | FDA UDI | Class II | Active |
| Holder for Aeroneb | 6670212 | FDA UDI | Class II | Active |
| Adap etCO2 Airway Neo | 4721788 | FDA UDI | Class II | Active |
| CO2 absorber disposable, 12 pcs | 6677845 | FDA UDI | Class I | Active |
| Rail clamp 10x25, Humidifier holder | 6881088 | FDA UDI | Class II | Active |
| Breath syst 15mm (Aktive Humid)Hytr | 6692155 | FDA UDI | Class I | Unknown |
| NIV Mask (L) disposable MAQUET | 6694595 | FDA UDI | Class I | Unknown |
| User Interface Holder | 6880099 | FDA UDI | Class II | Active |
| Gas cylinder restrainer assy | 6883880 | FDA UDI | Class II | Active |
| CO2/Y sensor adapter, 10pcs/pkg | 6880104 | FDA UDI | Class II | Active |
| Edi Cath. 6Fr/50cm 1/pkg | 6686402 | FDA UDI | Class II | Active |
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