CARDEA GmbH & Co. KG
DE-MF-000006460 · Germany · Harsleben
CARDEA GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 138 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 138 |
|---|
Among these devices, 138 are declared sterile.
Devices declared under this manufacturer
- Druckmeßleitung LL ml. / wl. 150 cm neutral
- Infusionsleitung mit Rückschlagventil
- MR- CT Verbinder 75cm mit Rückschlagventil
- MR-CT-Verbinder 150 cm m. endständ. RV und Y Verbinder
- RöKo-Filling-Line 1
- Transaflow Hochdruckverbinder mit Rotationsadapter 240cm
- Transaflow Multi-APS 11 safety MR/CT mehrfach Füllsystem zur Kontrastm
- Transaflow Multi-APS 16 L safety MR/CT mehrfach Füllsystem zur Kontras
- Transaflow Multi-APS 24 safety MR/CT mehrfach Füllsystem zur Kontrastm
- Transaflow Multi-APS 24h safety MR/CT mehrfach Füllsystem zur Kontrast
- Transaflow PWL-20 Patientenwechselleitung 2V 200cm
- Transaflow PWL-25 Patientenwechselleitung 2V 250cm
Showing 12 of 138 declared devices.
Catalogue references include 04260590632692, 2215010, 2580445, 2580623, 2590402, TM0449.
European nomenclature codes declared: A03020199, Z11050185, A03020102, A03020101.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 138 |
| Country of registration | Germany |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 138 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. CARDEA GmbH & Co. KG was not found in either the U.S. or the Canadian register.