Herb-Pharma Corporation s.r.o.
SK-MF-000005839 · Slovakia · Velke Ludince
Herb-Pharma Corporation s.r.o. is registered in the European database on medical devices as a manufacturer, with 21 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 5 |
|---|---|
| Class IIa | 16 |
Most frequent device types declared: 02023, 14007, 14008.
Devices declared under this manufacturer
- fytofontana AURECON natural ear candles
- fytofontana AURECON plus ear candles
- fytofontana Aurecon DRY spray
- fytofontana Aurecon Forte spray
- fytofontana Aurecon drops
- fytofontana Aurecon drops forte
- fytofontana GYNTIMA Hyaluronic vaginal suppositories
- fytofontana GYNTIMA Menopausa vaginal suppositories
- fytofontana GYNTIMA Probiotica Forte vaginal suppositories
- fytofontana HEMORRELAX rectal cream
- fytofontana HEMORRELAX suppositories
- fytofontana VIROSTOP nasal spray
Showing 12 of 21 declared devices.
Catalogue references include 02025, 02026, 04002, 04018, 04019, 10034.
European nomenclature codes declared: Q03040299, M9002,V9099, U0803, V9099, M9002.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 21 |
| 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 | 13 |
|---|---|
| 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. Herb-Pharma Corporation s.r.o. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
2026-MDR/QS-010/A | supplemented | 2029-04-18 |
2026-MDR/QS-009/A | supplemented | 2029-04-18 |
2025-MDR/QS-003/A | supplemented | 2029-04-18 |
2024-MDR/QS-023/B | supplemented | 2029-04-18 |