BISMED, s.r.o.
CZ-MF-000040871 · Czechia · Kuřim
BISMED, s.r.o. is registered in the European database on medical devices as a manufacturer, with 35 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 35 |
|---|
Most frequent device types declared: Suction Connecting Tube CH25 and CH30; Sací spojovací hadice CH25 a CH, Vacuum bottle for wound drainage Redon with tube; Podtlaková lahev pro.
Among these devices, 20 are declared sterile, 12 active.
Catalogue references include 07.068.25.200, 07.068.25.600, 07.068.30.320, 07.068.30.500, 99.000.22.799, 99.068.25.250.
European nomenclature codes declared: A060102, A0601010101.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 35 |
| Country of registration | Czechia |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 35 |
|---|---|
| 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. BISMED, s.r.o. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
2025-MDR/QS-025/A | supplemented | 2030-03-25 |
2025-MDR/QS-024/A | issued | 2030-03-25 |