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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 1 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Breathing system dual heated active humidification, 10mm | 6693742 | EUDAMED | Class IIa | Active |
| NIV Mask (S) reuse, 2 ports, MAQUET | 6694582 | FDA UDI | Class I | Unknown |
| Anest mask reuse, size 1 with MAQUET | 6694570 | EUDAMEDFDA UDI | Class I | Active |
| AFGO kit (onsite upgrade) | 6686860 | FDA UDI | Class II | Active |
| Edi Module cable with test plug | 6671960 | FDA UDI | Class II | Active |
| Breath circuit 15 disp 1.2m | 6694600 | FDA UDI | Class I | Active |
| Y-Piece W/Sampl. Port | 6880253 | FDA UDI | Class II | Active |
| Expiratory Cassette incl. 6447960 | 6696947 | FDA UDI | Class II | Active |
| Edi Cath. 8Fr/100cm 1/pkg | 6686405 | FDA UDI | Class II | Active |
| Servo-i Holder | 6671717 | FDA UDI | Class II | Active |
| Pat syst 10mm HME Hytrel Reus 1.5m | 6692152 | FDA UDI | Class I | Active |
| Breath syst 15mm HME & MR 3M Disp | 6694140 | FDA UDI | Class I | Active |
| Compressor Mini 115V 60Hz | 6481779 | FDA UDI | Class II | Active |
| Pendant Bed/Holder | 6693710 | FDA UDI | Class II | Active |
| Y sensor neonatal, disposable, 5 pcs/pkg | 6693667 | FDA UDI | Class II | Active |
| Teleflex Adapter, Humidifier Holder | 6880102 | FDA UDI | Class II | Active |
| EXPIRATORY CASSETTE, SERVO-n | 6693750 | FDA UDI | Class II | Active |
| Gas Cylinder Restrainer Kit Us | 6885179 | FDA UDI | Class II | Active |
| Maquet filling adapter isoflur | 6682290 | FDA UDI | Class II | Active |
| Aeroneb Module Solo kit, SERVO-i | 6685347 | FDA UDI | Class II | Active |
| Anesthesia mask disp, size 3 | 6694262 | FDA UDI | Class I | Unknown |
| Angled Adapter 22-15mm/15mm 5Pc | 9037730 | FDA UDI | Class II | Active |
| Anest mask reuse, size 2 with MAQUET | 6694572 | EUDAMEDFDA UDI | Class I | Active |
| Edi Cath. 6Fr/49cm 1/pkg | 6686400 | FDA UDI | Class II | Active |
| Vaporizer Sevoflurane, QUICK FILL | 6886611 | FDA UDI | Class II | Active |
| Pat syst 22mm HME HME Si Reus 1.5m | 6691970 | FDA UDI | Class I | Active |
| Breath syst 22mm HME & MR 3M Disp | 6694135 | FDA UDI | Class I | Active |
| AFGO adapter kit onsite upgrade | 6887999 | FDA UDI | Class II | Active |
| Servo-air Lite | 6893200 | FDA UDI | Class II | Active |
| Expiratory heater, SERVO DuoGuard | 6693732 | FDA UDI | Class I | Active |
| Breath syst 10mm HME & MR 3M Disp | 6694145 | FDA UDI | Class I | Active |
| Gas sampling line (M/M connectors) 4.5m | 6887044 | FDA UDI | Class II | Active |
| Anest mask reuse, size 0 with MAQUET | 6694567 | EUDAMEDFDA UDI | Class I | Active |
| Edi Catheter ENFit 8Fr/125 cm, 5pcs | 6883902 | EUDAMEDFDA UDI | Class II | Active |
| Y Piece Holder/Hook Servo Vent Handl | 6880548 | FDA UDI | Class II | Active |
| Bacterial filter 5pcs | 6887498 | FDA UDI | Class II | Active |
| Breath syst 22mm (Aktive Humid)Hytr | 6691962 | FDA UDI | Class I | Unknown |
| Carrier SERVO-i, Robust, flatpack | 6671675 | FDA UDI | Class II | Active |
| Tubing hook large | 6887712 | FDA UDI | Class II | Active |
| Cart SERVO-i, w/o Drawers, Flatpack | 6682722 | FDA UDI | Class II | Active |
| Breathing bag anest disp 2L compl | 6694610 | FDA UDI | Class I | Active |
| Humidifier holder for rail 10 x 25/10 x 30 mm | 6545110 | FDA UDI | Class II | Active |
| Breath syst 10mm HME Disp1.2m | 6694105 | FDA UDI | Class I | Active |
| Volu.reflec, incl.Reflector socket | 6680327 | FDA UDI | Class II | Active |
| Y Sensor Infant (10 pcs) | 6670662 | FDA UDI | Class II | Active |
| Absorber sealing, 2 each | 6883462 | FDA UDI | Class II | Active |
| Servo-i Base Unit | 6487800 | FDA UDI | Class II | Active |
| Extra Volume reflector | 6888985 | FDA UDI | Class II | Active |
| Humidifier Holder | 6693735 | FDA UDI | Class II | Active |
| Tube Joint Adlt 22mm OD/15mm ID | 6425581 | FDA UDI | Class I | Active |
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