PRZEDSIĘBIORSTWO INNOWACYJNO-HANDLOWE "VARIA" Sp. z o.o.
PL-MF-000051067 · Poland · Poznań
PRZEDSIĘBIORSTWO INNOWACYJNO-HANDLOWE "VARIA" Sp. z o.o. is registered in the European database on medical devices as a manufacturer, with 152 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 152 |
|---|
Devices declared under this manufacturer
- Papier EKG Aspel Ascard 3 / 104x40 bez zadruku
- Papier EKG Aspel Ascard 33/5, 110x10
- Papier EKG Aspel Ascard-A4 / B56 / Mr Blue / Mr Silver / Mr Grey / 112
- Papier EKG CardioSmart, Marquette MAC1200 / MAC1600 / MAC2000, Mindray
- Papier EKG Mortara Eli 230 / 210x20
- Papier EKG Nihon Kohden ECG-9130 / ECG-9110 / Edan SE-1201/ 210x140x21
- Papier EKG ST- JUDE MED-250, 210x140x200
- Papier EKG Schiller AT-2 / 210x280x215
- Papier EKG Sonoscape IE-12 / 210x150x200
- Papier Mortara Eli 250/350, 215x280x250
- Papier Sunray SRF628B 112x100x150 (210)
- Papier do drukarki laboratoryjnej 110x20
Showing 12 of 152 declared devices.
Catalogue references include T5R11020E12O0000, T5R11020E12O0005, T5R21020E19R0000, T5Z210140200OM00, T5Z210150200AM00, T5Z210280215VM00.
European nomenclature codes declared: Z1302, Z1399.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 152 |
| 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 | 152 |
|---|---|
| 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. PRZEDSIĘBIORSTWO INNOWACYJNO-HANDLOWE "VARIA" Sp. z o.o. was not found in either the U.S. or the Canadian register.