Satatuote Oy
Satuote
Wij leveren milieuvriendelijke, hoogwaardige verpakkingsoplossingen voor de medische industrie en daarbuiten, die uw bedrijf ondersteunen van ontwerp tot levering. Ontdek hoe wij uw klantervaring naar een hoger niveau tillen.
- Type
- brand seeking distribution
- Location
- Germany
- Website
- https://satatuote.com
- Categories
- Medische en gezondheidszorgbenodigdheden, Verpakkings- en drukbenodigdheden
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