Medion Grifols Diagnostics AG
CH-MF-000024272 · Switzerland · Düdingen
Medion Grifols Diagnostics AG is registered in the European database on medical devices as a manufacturer, with 26 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Most frequent device types declared: Anti-Lua, Enlisst-II, Grifols sCD38, Neutr-AB II, Specific Albumin 22%.
Authorised representative in the Union: Diagnostic Grifols, S.A..
Devices declared under this manufacturer
- Anti-C3d
- Anti-Dia Dual
- Anti-Kpb Dual
- Anti-Lua
- Anti-Lub Mono-Type Dual
- Anti-N (LN3/MN879) Mono-Type
- Anti-S Mono-Type
- Anti-s Mono-Type
- Bromelase 30
- Data-Cyte Extend 0.8%
- Diego(a)-Cyte 3%
- Mi(a)-Cyte 0.8%
Showing 12 of 26 declared devices.
Catalogue references include 213229, 213295, 213422, 213566, 213578, 213685.
European nomenclature codes declared: W0103030501, W0103030303, W0103030306, W0103030307, W0103030305, W0103030399.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | MEDION GRIFOLS DIAGNOSTICS AG (CH) · FDA 3002806769 |
| Devices in EUDAMED | 26 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 26 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | MEDION GRIFOLS DIAGNOSTICS AG |
What it holds in Canada
| Licences on record | 5 |
|---|---|
| Currently active | 0 |
| Class 3 devices | 5 |
| First licensed | 2012-06-27 |
Licence types: Single Device (3), Device Family (2).
Licensed under: REVERSE-CYTE (DETERMINATION OF THE REVERSE ABO, REAGENT RED BLOOD CELLS FOR DETECTION OF UNEXP, EXTENDED IV CONTROL, ANTI-CW MONO-TYPE DUAL (MS-110), ANTI-D IGG MONO-TYPE.
North American profile: Both markets. Medion Grifols Diagnostics AG is registered in both the United States and Canada.