Satatuote Oy
Satatuote
Kami memberikan solusi pengemasan yang ramah lingkungan dan berkualitas tinggi untuk industri medis dan lebih dari itu, mendukung bisnis Anda mulai dari desain hingga pengiriman. Temukan bagaimana kami meningkatkan pengalaman pelanggan Anda.
- Type
- brand seeking distribution
- Location
- Germany
- Website
- https://satatuote.com
- Categories
- Perlengkapan Medis & Kesehatan, Perlengkapan Pengemasan & Percetakan
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