ROYAX, s.r.o.
CZ-MF-000020709 · Czechia · Netvořice
ROYAX, s.r.o. is registered in the European database on medical devices as a manufacturer, with 20 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 20 |
|---|
Most frequent device types declared: FFP3 NR Type IIR, R-DP-R-FFP2-01.
Devices declared under this manufacturer
- Chair-stretcher Arsh
- Detachable Power Assisted Stretcher Valens RX6
- Detachable incubator stretcher SARIR
- FFP3 NR Medical Particle Filtering Half Mask
- FFP3 NR Medical Particle Filtering Half Mask –5pcs
- Foldable Carrying Chair PHAETON
- Foldable Carrying Chair STAIRMANN
- Foldable Carrying Chair STAIRMANN PLUS
- Folding Stretchers (3 Fold Camil)
- Head Immobilizer EVA
- Roll-in Stretcher COMPACT
- Scoop Stretcher
Showing 12 of 20 declared devices.
Catalogue references include R-DP-R-FFP3-01, R-S-CC-01, R-S-CS-ARSH-01, R-S-RS-SA-02, R-S-RS-VRX-02, R-S-SC-A-02.
European nomenclature codes declared: V08050199, T020604, V08050102, V080502, V08050103, V0804.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 20 |
| Country of registration | Czechia |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 20 |
|---|---|
| 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. ROYAX, s.r.o. was not found in either the U.S. or the Canadian register.