Satatuote Oy
Satatuote
Dostarczamy przyjazne dla środowiska, wysokiej jakości rozwiązania opakowaniowe dla branży medycznej i nie tylko, które wspierają Twój biznes od projektu po dostawę. Odkryj, jak podnosimy jakość obsługi klienta.
- Type
- brand seeking distribution
- Location
- Germany
- Website
- https://satatuote.com
- Categories
- Artykuły medyczne i związane z opieką zdrowotną, Materiały do pakowania i drukowania
Verified facts
- web-presence-since (green), checked 2026-08-03 Internet Archive (Wayback)
- domain-registered (green), checked 2026-08-02 Domain registry record
- sanctions-clear (green), checked 2026-08-16 OpenSanctions
- debarment-clear (green), checked 2026-08-16 OpenSanctions
Profiles
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)
- If the goods are paper, board or printed products, EU imports fall under the Deforestation Regulation (EUDR) due-diligence regime; packaging machinery itself does not. European Commission (EUDR)
- No public registry exists for certificates of this kind in this sector: conformity is declared by the manufacturer. European Commission: CE marking, manufacturer's conformity assessment