Aurena Laboratories AB
SE-MF-000002890 · Sweden · Karlstad
Aurena Laboratories AB is registered in the European database on medical devices as a manufacturer, with 124 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 124 |
|---|
Most frequent device types declared: 2005-1, REF 2001, REF 2002, REF 2003, REF 2005.
Among these devices, 116 are declared sterile, 121 active.
Devices declared under this manufacturer
- BUSINESSCARE® Eyewash
- Eyewash
- Marissimo® Baby Sprej
- Marissimo® Extra Forte Sprej
- Marissimo® Soft Mini Sprej
- Mediclear Wound and Eye Wash Spray
- Presto® WOUND AND EYE WASH SPRAY, 250 ml
- QUAZZIISO
- Rhinox Nasal Spray, 50 ml
- Spray anti-adhésif
- Sårtvätt & Ögondusch
- WUND- UND AUGENSPRAY
Showing 12 of 124 declared devices.
Catalogue references include 301330, 301370, 301375, 301423, 301470, 301479.
European nomenclature codes declared: Q030103, M04040101, Q0299, Q03040299, M9003, M04040501.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | AURENA LABORATORIES AB (SE) · FDA 3006542993 |
| Devices in EUDAMED | 124 |
| Country of registration | Sweden |
Device-level evidence
| Devices with a numeric GTIN | 124 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | AURENA LABORATORIES AB |
North American profile: Both markets. Aurena Laboratories AB is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
28620131862-04 | supplemented | 2027-10-27 |