UNOMEDICAL S.R.O.
- Type
- Manufacturer
- Location
- MICHALOVCE Kosicky, Slovakia
- Categories
- Medical & Healthcare Supplies
Listed in a source registry
Verified facts
- market-access-eu (green), checked 2026-08-22 TRACES NT, European Commission register of approved establishments (DG SANTE)
- facility-registered (green), checked 2026-08-17 US FDA device establishment registration (openFDA)
- registry-activity (green), checked 2026-08-21 Enviroportál SAŽP, centrálny informačný systém EIA/SEA (environmental impact assessment, Slovakia)
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)