PRIME Medical Solutions
BE-MF-000018858 · Belgium · Hasselt
PRIME Medical Solutions is registered in the European database on medical devices as a manufacturer, with 36 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 36 |
|---|
Most frequent device types declared: D-Series, Q2K-02-Series, Q2K-03-Series, Q3-Series, Q5.
Among these devices, 26 are declared active.
Devices declared under this manufacturer
- C_1034_S1 (100x200), BariCell
- C_1034_S1 (140x200), BariCell
- C_512/834_S0 (85x200), ProCell
- D30
- FlowCell
- M_1034N MR (120x200)(V1)
- M_512N MR Plus (85x200)(V1)
- M_834N MR T (85x200)(V1)
- M_834N MR T (90x200)(V1)
- M_Hybr (90x200)(V1)
- Optiva III
- Optiva IV
Showing 12 of 36 declared devices.
Catalogue references include CSS11201441, CUS05208551, MHT72090100, MRP52085100, PD30001P01, PQ05001P01.
European nomenclature codes declared: V080701, V0880.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 36 |
| Country of registration | Belgium |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 36 |
|---|---|
| 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. PRIME Medical Solutions was not found in either the U.S. or the Canadian register.