Getinge Disinfection AB
SE-MF-000001012 · Sweden · Växjö
Getinge Disinfection AB is registered in the European database on medical devices as a manufacturer, with 251 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 241 |
|---|---|
| Class IIb | 10 |
Devices declared under this manufacturer
- Class I Accessories
- Getinge AER CONNECTORS
- Getinge EDS8 IRRIGATORS
Showing 12 of 251 declared devices.
Catalogue references include 6002526801, 6028423901, 6028662101, 6036008201, 6043095901, P01039717.
European nomenclature codes declared: S9099, Z12011301, D0902, S900101, D050103, Z12011314.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | GETINGE DISINFECTION AB (SE) · FDA 9616031 |
| Devices in EUDAMED | 251 |
| Country of registration | Sweden |
Device-level evidence
| Devices with a numeric GTIN | 251 |
|---|---|
| Found in the U.S. device database | 78 |
| Share | 31.1 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | GETINGE DISINFECTION AB |
What it holds in Canada
| Licences on record | 2 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 2 |
| First licensed | 1999-06-14 |
Licence types: Device Family (1), Single Device (1).
Licensed under: GETINGE WASHER/DISINFECTOR, GETINGE AQUADIS ENDO 110.
North American profile: Both markets. Getinge Disinfection AB is registered in both the United States and Canada.