ArjoHuntleigh AB
SE-MF-000000696 · Sweden · Malmö
ArjoHuntleigh AB is registered in the European database on medical devices as a manufacturer, with 8 654 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 8 506 |
|---|---|
| Class IIb | 148 |
Most frequent device types declared: 526000-03, 8X13GY113DCABA, 9X21AE111BFCSA, AL21000-EU, CDB6021-01.
Among these devices, 7 557 are declared active, 3 800 with a measuring function.
Devices declared under this manufacturer
- CITADEL PLUS
- Conformx
- ENTERPRISE 5000X
- ENTERPRISE 8000X
- HYDROVEN
- Maxi Move
- Maxi Sky 2
- SMARTSIGNS
- SONICAID
- Sling - Amputee clip bathing in situ
- Symbliss Bath Chair
- System 2000 - Primo
Showing 12 of 8 654 declared devices.
Catalogue references include 8X23HY113BFAJA, AR31211EU1001, AR32211GB2001, E5X1DR112CDDAA, KMCEXN-D-99, MAA2080M0S.
European nomenclature codes declared: Y093399, Z12011301, V08060103, V08060105, V080702, V0805030102.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ARJOHUNTLEIGH AB (SE) · FDA 3002806395 |
| Devices in EUDAMED | 8 654 |
| Country of registration | Sweden |
Device-level evidence
| Devices with a numeric GTIN | 8 654 |
|---|---|
| Found in the U.S. device database | 323 |
| Share | 3.7 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | ARJOHUNTLEIGH AB |
What it holds in Canada
| Licences on record | 20 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 20 |
| First licensed | 1999-04-30 |
Licence types: System (10), Device Family (7), Single Device (3).
Licensed under: AC550 FLOWTRON EXCEL, THERAPULSE PULSATING AIR AND LOW AIRLOSS THERA, ALTERNATING PRESSURE AIR FLOTATION MATTRESS, FLOWTRON UNIVERSAL, ALTERNATING PRESSURE MATTRESS PUMPS, MAXXAIR ETS.
North American profile: Both markets. ArjoHuntleigh AB is registered in both the United States and Canada.