Maquet Critical Care AB
SE-MF-000001264 · Sweden · Solna
Maquet Critical Care AB is registered in the European database on medical devices as a manufacturer, with 71 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 52 |
|---|---|
| Class IIb | 19 |
Most frequent device types declared: 6891100, PV8810.
Among these devices, 18 are declared sterile, 21 active, 19 with a measuring function.
Devices declared under this manufacturer
- Breath sys HFOV 15mm Dual heat/act
- Breathing Bag set 22mm Ed2
- Breathing bag Anesthesia, Disposable 1L
- Breathing bag Anesthesia, Disposable 3L
- Breathing system dual heated active humidification, 10mm
- Breathing system dual heated active humidification, 22mm
- Edi Catheter ENFIT 6Fr/48 cm
- Edi Catheter ENFIT 6Fr/50 cm
- Flow-i C30
- Gas Sampling line 2.5m
- PiCCO Catheter
- Pulsiocare
Showing 12 of 71 declared devices.
Catalogue references include 6692205, 6692217, 6692222, 6693737, 6693742, 6883899.
European nomenclature codes declared: C019004, G02020101, Z1203010101, R02010101, R020199, R03020101.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | MAQUET CRITICAL CARE AB (SE) · FDA 8010042 |
| Devices in EUDAMED | 71 |
| Country of registration | Sweden |
Device-level evidence
| Devices with a numeric GTIN | 71 |
|---|---|
| Found in the U.S. device database | 42 |
| Share | 59.2 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | MAQUET CRITICAL CARE AB |
What it holds in Canada
| Licences on record | 13 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 8 |
| Class 3 devices | 5 |
| First licensed | 2001-12-03 |
Licence types: System (6), Device Family (3), Single Device (2), Device Group Family (1).
Licensed under: SERVO-I VENTILATOR SYSTEM, SERVO GUARD, SERVO-S VENTILATOR SYSTEM, FLOW-I ANESTHESIA SYSTEM, ANESTHESIA PATIENT CONNECTIONS, PATIENT CONNECTIONS FOR VENTILATION.
North American profile: Both markets. Maquet Critical Care AB is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G10 072017 0015 | issued | 2030-02-16 |