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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 3 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Conn Tube 22mm Int 50m disposable | 6189646 | FDA UDI | Class II | Active |
| Breath syst 10mm Act Disp 2.2m10pcs | 6692170 | FDA UDI | Class I | Unknown |
| Gas cylinder Restrainer Servo-s | 6650514 | FDA UDI | Class II | Active |
| Manual Breathing bag support arm, rigid | 6880157 | FDA UDI | Class II | Active |
| Breathing Circuit 15mm Reus Hytrel | 6692182 | FDA UDI | Class I | Active |
| Adap etCO2 Airway Adult | 4721796 | FDA UDI | Class II | Active |
| Drawer for Low mobile carts | 6890365 | FDA UDI | Class II | Active |
| Vaporizer Sevoflurane, SAFE-T-SEAL | 6887135 | FDA UDI | Class II | Active |
| Vaporizer Desflurane, Saf-Fil | 6886631 | FDA UDI | Class II | Active |
| NIV Mask (M) reuse, 2 ports, MAQUET | 6694585 | FDA UDI | Class I | Unknown |
| etCO2 Airway adapter Neonatal disp. 1pcs | 6884536 | FDA UDI | Class II | Active |
| Tubing hook small | 6887713 | FDA UDI | Class II | Active |
| Starter Kit Ventilation, Pediatric | 6696705 | FDA UDI | Class I | Unknown |
| Gas Trolley for Mobile Cart Servo-i | 6532910 | FDA UDI | Class II | Active |
| Flexible manual breathing bag arm | 6887717 | FDA UDI | Class II | Active |
| Hytrel slang 10mm 30cm | 6692317 | FDA UDI | Class I | Active |
| Anesthesia mask disp, size 4 | 6694265 | FDA UDI | Class I | Unknown |
| Adapter 15-10mm w/ Drip Edge 5Pc. | 6696744 | FDA UDI | Class II | Active |
| Hook w/ Hook Holder | 9368952 | FDA UDI | Class II | Active |
| Anesthesia mask disp, size 5 | 6694267 | FDA UDI | Class I | Unknown |
| Humidification holder assy | 6692660 | FDA UDI | Class II | Active |
| Air inlet filter | 6882408 | FDA UDI | Class II | Active |
| Pat syst 22mm HME Hytrel Reus 1.5m | 6691967 | FDA UDI | Class I | Active |
| Breathing Circuit 10mm Reus Hytrel | 6692185 | FDA UDI | Class I | Active |
| Breath syst 10mm (Aktive Humid)Sili | 6692162 | FDA UDI | Class I | Unknown |
| Support Arm 177 | 6481720 | FDA UDI | Class II | Active |
| Breath syst 22mm Heater Humidif.Si | 6695165 | FDA UDI | Class I | Unknown |
| Volume reflector | 6887614 | FDA UDI | Class II | Active |
| Vaporizer Isoflurane, MAQUET filling | 6886621 | FDA UDI | Class II | Active |
| Edi Cath. 8Fr/125cm 1/pkg | 6686407 | FDA UDI | Class II | Active |
| Cabinet | 6882074 | FDA UDI | Class II | Active |
| Breathing bag anest disp 1L compl | 6694607 | FDA UDI | Class I | Active |
| Pat syst 15mm HME Hytrel Reus 1.5m | 6692150 | FDA UDI | Class I | Active |
| Breathing Circuit 22mm Reus Hytrel | 6692180 | FDA UDI | Class I | Active |
| Maquet filling adapter sevoflur | 6682292 | FDA UDI | Class II | Active |
| Edi Catheter ENFit 16Fr/125 cm, 5pcs | 6883904 | FDA UDI | Class II | Active |
| Shelf Base Servo-s | 6650001 | FDA UDI | Class II | Active |
| Shelf kpl | 6487073 | FDA UDI | Class II | Active |
| Vaporizer Isoflur. Maquet filling | 6682280 | FDA UDI | Class II | Active |
| Cart SERVO-i, w/ Drawers, mounted | 6486729 | FDA UDI | Class II | Active |
| Anest mask reuse, size 4 with MAQUET | 6694577 | EUDAMEDFDA UDI | Class I | Active |
| CO2 absorber (disposable), 12 pcs/pkg | 6887738 | FDA UDI | Class I | Active |
| Cart SERVO-i, w/ Drawers, flatpack | 6568146 | FDA UDI | Class II | Active |
| Breath syst 10mm (Aktive Humid)Hytr | 6692157 | FDA UDI | Class I | Unknown |
| Rail Clamp 10x30mm | 6038819 | FDA UDI | Class II | Active |
| NIV Mask (M) disposable MAQUET | 6694592 | FDA UDI | Class I | Unknown |
| Expiratory Cassette, Dark Gray | 6693752 | FDA UDI | Class II | Active |
| 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 |
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