ZARYS International Spółka z ograniczoną odpowiedzialnością
PL-MF-000000410 · Poland · Zabrze
ZARYS International Spółka z ograniczoną odpowiedzialnością is registered in the European database on medical devices as a manufacturer, with 1 303 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 1 302 |
|---|---|
| Class I | 1 |
Most frequent device types declared: DS-WKL-00667, OP-CES-02784, OP-CES-02815, OP-CHI-00522, OP-LAP-00842.
Among these devices, 747 are declared sterile.
Devices declared under this manufacturer
- DUODENAL TUBE
- PEZZER CATHETER
- STOMACH TUBE
- TWO-WAY FOLEY CATHETER with plastic valve
- dicoNEX Single use syringe, 3-part
- mediCARE nitrile Hydra+ Nitrile examination gloves, powder-free, non-s
- omegapack Zestaw chirurgiczny 22
- omegapack Zestaw do cięcia cesarskiego 65
- omegapack Zestaw opatrunkowy 130
- orthoSYNTHETIC Orthopedic padding, synthetic, poliester
- previoMedical Patient's underpants for the operating room, non-sterile
- yellowBAND Cohesive bandage
Showing 12 of 1 303 declared devices.
Catalogue references include 010ML-3CZ-LL-R, OP-CES-02815, OP-OPA-00130, OS-83, PM-MI6Z-XL, YCB-545-W.
European nomenclature codes declared: V0599, T01020204, M0599, U010201, M030402020101, T020102.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 1 303 |
| 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 | 1 303 |
|---|---|
| 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. ZARYS International Spółka z ograniczoną odpowiedzialnością was not found in either the U.S. or the Canadian register.