GEM SRL
IT-MF-000012892 · Italy · VIAREGGIO
GEM SRL is registered in the European database on medical devices as a manufacturer, with 53 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 34 |
|---|---|
| Class I | 19 |
Most frequent device types declared: G-NB-2;G-NB2-75;G-NB2-60; G-NB2-50; G-NB2-35 ;G-NB2S-25, G2-NBT; G2-NBT-SMALL; G2-NBT-RIG; G2-NBT-SHORT; G2-NBT-SM-SHORT, GB-DS 30; GB-DS 60; GB-DS SH 30; GB-DS SH 30; GB-DS SH 60, G-NBOC2, G-NBOC2-25,G-NBOC2-35, G2-LPC;G2-LPC-RIG.
Among these devices, 53 are declared sterile, 19 implantable.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 53 |
| Country of registration | Italy |
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
ITD 1450390 1 | supplemented | 2028-11-14 |
CVD0027240225 | supplemented | 2029-05-15 |
CSQ0019240225 | supplemented | 2029-05-15 |
295/MDR | issued | 2031-06-03 |
0425-MDR-030094-00 | issued | 2029-09-11 |