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: AQUARAY, AQUANEA, ORIONMED, Leno, Vista ,Patihoist, Lifteo, Tonya, Levitop, Diana II, Neuroforma Cognitive Senior, OKO, SOLMED UNO, DUO, TRIO.
Among these devices, 121 are declared active.
Devices declared under this manufacturer
- Eline
- Neuroforma Cognitive Senior
- OKO z czterema optotypami cyfry, litery, obrazki, haki
- OKO z dwoma optotypami cyfry, litery
- OKO z dwoma optotypami: cyfry, obrazki
- OKO z trzema optotypami cyfry, litery, obrazki
- ORIONMED
- SOLMED TRIO
- Tonya II kinderlift
- VertiAid UNI
- VertiHelp UNI eFlow
- VertiUp Plus
Showing 12 of 145 declared devices.
European nomenclature codes declared: Z120602, V0805030102, Z1212012001, Z120618, Z12069099, Z129017.
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 |
Device-level evidence
| Devices with a numeric GTIN | 145 |
|---|---|
| Found in the U.S. device database | 3 |
| Share | 2.1 % |
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. MEDEN-INMED SP. Z O.O. is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
HZ 1023782-1 | reissued | 2031-06-01 |