(주)뉴캐스트인더스트리
- Type
- Manufacturer
- Location
- Ulsan, South Korea
- Categories
- Medische en gezondheidszorgbenodigdheden
Listed in a source registry
Korea Industrial Complex Corporation registered-factory list (data.go.kr)
Verified facts
- registered-manufacturer (green), checked 2024-12-31 Korea Industrial Complex Corporation registered-factory list (data.go.kr)
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)