PROTETIKA, a.s.
SK-MF-000004489 · Slovakia · Bratislava
PROTETIKA, a.s. is registered in the European database on medical devices as a manufacturer, with 565 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 565 |
|---|
Most frequent device types declared: Ankle-foot orthose, Cervical spine orthose, Insoles, Knee orthose, Lumbosacral orthose.
Devices declared under this manufacturer
- Bandáž stehna, neoprén, ST-1/25 P, pravá
- Bandáž stehna, neoprén, ST-1/30 P, pravá
- Golier extenčný molitanový, ľahký, 8 cm
- Gumotextilná ortéza zápästia a palca , ZA-22, pravá
- Neoprénová bandáž drieku, PA-1
- Neoprénová bandáž kolena, KO-4
- Ortopedické vložky pre pozdĺžne a priečne ploché nohy, multiform, dáms
- Ortopedické vložky pre pozdĺžne ploché nohy, koža, pánske
- Ortopedické vložky pre pozdĺžne ploché nohy, multiform, detské
- Ortéza kolena so silikónovou pelotou, KO-42
- Ortéza členka so silikónovými pelotami a gumovým ťahom, ČL-41
- Pavlíkove remence
Showing 12 of 565 declared devices.
Catalogue references include 8585003403703, 8585003403796, 8585003405554, 8585003406988, 8585003409835, 8585003411623.
European nomenclature codes declared: Y061203, Y061209, Y060308, Y060612, Y060615, Y06120601.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 565 |
| Country of registration | Slovakia |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 565 |
|---|---|
| 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. PROTETIKA, a.s. was not found in either the U.S. or the Canadian register.