Fresenius Kabi AG
DE-MF-000009273 · Germany · Bad Homburg
Fresenius Kabi AG is registered in the European database on medical devices as a manufacturer, with 61 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 60 |
|---|---|
| Class IIb | 1 |
Among these devices, 59 are declared sterile, 1 with a measuring function.
Devices declared under this manufacturer
- Ambix NONCORstick® Safe 20Gx14mm max 21 bar/300 psi-max 4ml/s
- Back Check Valve
- Back Check Valve with Protection Cap
- Capuchon de transfert
- Closing-Cap Luer, yellow
- Extra-Spike® Plus, 5 µm, blue
- Extra-Spike® Plus, green
- Freka® Mix Bag 3000 mL + 3-filling leads
- Freka® Stoma Measuring Device
- Infufil Air 96h, 0.2 µm, positive, 10 cm2
- Injectomat® Syringe 50 ml with cannula 1.8 mm x 38 mm
- Perineal Drape
Showing 12 of 61 declared devices.
Catalogue references include 2902812, 2909502, 7752029, 8084261, 8502802, B285141.
European nomenclature codes declared: A0799, V020399, V020380, G0280, A060399, A03020102.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | FRESENIUS KABI AB (SE) · FDA 3002631703 |
| Devices in EUDAMED | 61 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 61 |
|---|---|
| Found in the U.S. device database | 1 |
| Share | 1.6 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | FRESENIUS KABI AG |
What it holds in Canada
| Licences on record | 54 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 40 |
| Class 3 devices | 14 |
| First licensed | 1999-02-16 |
Licence types: System (17), Device Family (14), Device Group Family (12), Single Device (9).
Licensed under: BLOOD PACK UNIT WITH CPD, BLOOD PACK UNIT WITH CPDA-1, FENWAL PLASMACELL C DISPOSABLE SET, TRANSFER PACK, AMICUS SEPARATOR, AURORA PLASMAPHERESIS SYSTEM.
North American profile: Both markets. Fresenius Kabi AG is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G10 037258 0014 | supplemented | 2026-10-17 |