Ghimas S.p.A.
IT-MF-000017070 · Italy · Casalecchio di Reno (BO)
Ghimas S.p.A. is registered in the European database on medical devices as a manufacturer, with 90 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 83 |
|---|---|
| Class I | 5 |
| Class IIb | 2 |
Among these devices, 6 are declared sterile, 7 implantable, 1 reusable.
Devices declared under this manufacturer
- Gapseal Set
- PLASTOR
Showing 12 of 90 declared devices.
Catalogue references include Gapseal, PFON3D-MRKR11, PFONAP-EVO-TR3540, PFONAP-VP0004, PFONAT-IM0031, PFONAT-IMB130.
European nomenclature codes declared: Q010280, P900401, Q0199, Q03040299, Q01010301, P01020101.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 90 |
| Country of registration | Italy |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 77 |
|---|---|
| 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. Ghimas S.p.A. was not found in either the U.S. or the Canadian register.