MEDEN-INMED SP. Z O.O.
PL-MF-000001670 · Poland · Koszalin
MEDEN-INMED SP. Z O.O. is registered in the European database on medical devices as a manufacturer, with 145 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 141 |
|---|---|
| Class IIb | 4 |
Most frequent device types declared: OKO, VertiUp, Eline, TERAPEUTA, MONTANE, PRESTIGE, Z-ULTIMATE, ELEMENTAL, Leno, Vista ,Patihoist, Lifteo, Tonya, Levitop, Diana II, Z-ADVANCED, NEXUS, SAFARI, FLOW, MATERA, GALAXY.
Among these devices, 121 are declared active.
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 | Registered with FDA |
|---|---|
| Matched entry | MEDEN-INMED, SP. Z O.O. (PL) · FDA 3010067993 |
| Devices in EUDAMED | 145 |
| Country of registration | Poland |
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 1023782-1 | reissued | 2031-06-01 |