Satatuote Oy
Satatuote
우리는 의료 산업을 위한 환경 친화적인 고품질 포장 솔루션을 제공하며, 그 이상으로 디자인부터 납품까지 귀하의 비즈니스를 지원합니다. 고객 경험을 향상시키는 방법을 알아보세요.
- Type
- brand seeking distribution
- Location
- Germany
- Website
- https://satatuote.com
- Categories
- 의료 및 건강 관리 용품, 포장 및 인쇄 용품
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