Gofarm Sp. z o.o. Sp. k.
PL-MF-000003485 · Poland · Kraków
Gofarm Sp. z o.o. Sp. k. is registered in the European database on medical devices as a manufacturer, with 141 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 140 |
|---|---|
| Class IIb | 1 |
Most frequent device types declared: 100 ml, 12 pices, 125 ml, 125 ml, 200 ml, 15 g.
Devices declared under this manufacturer
- Dr.Max Żel na afty
- Herbitassin Iceland Moss HYDRO
- Hustensaft
- IriGo Zestaw do płukania nosa i zatok
- Irigo Zestaw do płukania nosa i zatok
- Nosoherb Nawilżająca maść do nosa
- RINGO Ringer's Lactate Nasal Spray
- Redcare Junior Hustensaft
- SEMA PROTECT Woda morska dla dzieci
- SEMA PROTECT Woda morska izotoniczna
- Sema Protect Zestaw do płukania nosa i zatok
- Solvax
Showing 12 of 141 declared devices.
Catalogue references include ENT02, ENT05, ENT10, ENT12, ENT25, ENT37.
European nomenclature codes declared: M9002, Q0399, Q030103, Q03040201, G05, V901001.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 141 |
| 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 | 34 |
|---|---|
| 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. Gofarm Sp. z o.o. Sp. k. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
1434-MDR-046/2025 | issued | 2030-12-15 |
1434-MDR-045/2025 | issued | 2030-12-11 |
1434-MDR-044/2025 | issued | 2030-11-12 |
1434-MDR-042/2025 | issued | 2030-11-05 |
1434-MDR-041/2025 | supplemented | 2030-11-05 |
1434-MDR-030/2025 | issued | 2030-09-24 |
1434-MDR-014/2025 | supplemented | 2030-06-22 |
1434-MDR-006/2026 | issued | 2031-03-31 |