LUXTURNA® (voretigene neparvovec-rzyl)
Perlengkapan Medis & Kesehatan, Amerika Serikat
LUXTURNA® (voretigene neparvovec-rzyl) adalah perusahaan perlengkapan medis & kesehatan yang berbasis di Amerika Serikat.
- Type
- Distributor
- Location
- United States
- Website
- https://luxturna.com
- Categories
- Perlengkapan Medis & Kesehatan
Verified facts
- sanctions-clear (green), checked 2026-08-09 OpenSanctions
- debarment-clear (green), checked 2026-08-09 OpenSanctions
- domain-registered (green), checked 2026-08-09 Domain registry record
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)