MEK-ORTO Sp. z o.o.
PL-MF-000019251 · Poland · Warszawa
MEK-ORTO Sp. z o.o. is registered in the European database on medical devices as a manufacturer, with 127 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 127 |
|---|
Most frequent device types declared: MEK 2002, MEK 3002, MEK 3009, MEK 3010, MEK 3015.
Devices declared under this manufacturer
- Orteza kręgosłupa szyjno-piersiowo-lędźwiowo-krzyżowego
- Orteza lędźwiowo-krzyżowo-piersiowa MEK 3009 XXL
- Pas brzuszny pooperacyjny
- Pas brzuszny pooperacyjny MEK 3002 beżowy 3XL
- Pas brzuszny pooperacyjny MEK 3002 czarny L
- Pas brzuszny pooperacyjny MEK 3002 czarny M
- Pas brzuszny pooperacyjny MEK 3002 czarny XS
- Pas dla kobiet w ciąży (przed i po porodzie) z fiszbinami MEK 3010 XL
- Stabilizator stawu nadgarstkowego MEK 6001 beżowy
- Stabilizator stawu nadgarstkowego MEK 6004 długi S prawa ręka
- Stabilizator stawu nadgarstkowego MEK 6004 krótka L lewa ręka
- Stabilizator stawu nadgarstkowego MEK 6004 krótka M lewa ręka
Showing 12 of 127 declared devices.
Catalogue references include 2002-cz-xxl, 3002-bz-3xl, 3002-cz-l, 3002-cz-m, 3010-xl, 3015-xs.
European nomenclature codes declared: Y060612, Y060621, Y060406, Y06120601, Y060306, Y060403.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 127 |
| Country of registration | Poland |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 127 |
|---|---|
| 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. MEK-ORTO Sp. z o.o. was not found in either the U.S. or the Canadian register.