PRIM, S.A.
ES-MF-000004651 · Spain · Madrid
PRIM, S.A. is registered in the European database on medical devices as a manufacturer, with 2 399 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 2 399 |
|---|
Most frequent device types declared: 70030201, BCXDAY.
Devices declared under this manufacturer
- Collare Philadelphia 961
- Collarín regulable en altura con apoyo mentoniano
- Corsé de Inmovilización Lumbosacra KNIGHT
- Faja Lumbosacra Neopreno TOPLINE OS
- Faja metatarsal post-operatoria L\t
- Férula pasiva corta de muñeca y pulgar (Quervain) XLL
- Ginocchiera Articolata XXL
- ISOVARPAAN OIKAISIJA
- Inmovilizador de clavícula Clavisan\t
- Inmovilizador digital recortable XL
- Muñequera sin pulgar larga ESSENCIAL MR
- PARALELAS 2 METROS \t
Showing 12 of 2 399 declared devices.
Catalogue references include 20121-08-60, 632 M, 949C XLL, 961TI S 4 1/4\, BXCSPOE1\t, C600 MR\t.
European nomenclature codes declared: Y060308, Y061203, Y061215, Y06120602, Y061209, Y060309.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | PRIM,S.A. (ES) · FDA 1000626221 |
| Devices in EUDAMED | 2 399 |
| Country of registration | Spain |
Device-level evidence
| Devices with a numeric GTIN | 2 399 |
|---|---|
| Found in the U.S. device database | 16 |
| Share | 0.7 % |
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: United States only. PRIM, S.A. is registered in the United States but was not found in the Canadian register.