Maquet SAS
FR-MF-000002926 · France · ARDON
Maquet SAS is registered in the European database on medical devices as a manufacturer, with 2 833 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 2 833 |
|---|
Most frequent device types declared: Lucea 10-40, Lucea 50-100, M Series, Volista Access, Volista Access II.
Among these devices, 2 830 are declared active.
Devices declared under this manufacturer
- PWDII50DF CL K4 XHS016 SAX1012
- PWDII50SF AIM CL XHS021 K4 1116
- PWDII55DF K3 SAX1416
- PWDII55DF VP AIM XHD127 K4 081011
- PWDII55DF VP K3 XHS016 SAX081012
- PWDII70DF K4 XHS016 SAX1012
- PWDII755SF AIM K3 081011
- PWDII75SF AIM K4 1416
- PWDII75SFDF AIM CL K4 1011
- PWDII75SFDF AIM XHS010 K3 081011
- PWDII77SF VP CL K3 XHS021 SAX081012
- VCSII40DF TK XO SAX1416
Showing 12 of 2 833 declared devices.
Catalogue references include ARDPWT209020A, ARDPWT209138A, ARDPWT239401A, ARDPWT259336A, ARDPWT609122A, ARDPWT659154A.
European nomenclature codes declared: Z12010701, Z12010799, Z12010702, Z12020405.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | MAQUET GMBH (DE) · FDA 8010652 |
| Devices in EUDAMED | 2 833 |
| Country of registration | France |
Device-level evidence
| Devices with a numeric GTIN | 2 833 |
|---|---|
| Found in the U.S. device database | 2 557 |
| Share | 90.3 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | MAQUET GMBH |
What it holds in Canada
| Licences on record | 2 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 2 |
| First licensed | 2018-05-23 |
Licence types: Device Family (2).
Licensed under: GETINGE GSS67N SERIES STEAM STERILIZER, GSS610N.
North American profile: Both markets. Maquet SAS is registered in both the United States and Canada.