Hiper Cast GmbH
Der CPP-Folienhersteller Hiper Cast GmbH mit Sitz in Österreich ist auf Retortenfolien, LTS-Folien für Monomaterialstrukturen aus 100 % PP sowie Folien von 25 µ bis 300 µ für die Bereiche Medizin, Pharma, Technik und Lebensmittel spezialisiert
- Type
- brand seeking distribution
- Location
- Hermagor, Austria
- Website
- hipercast.at
- Categories
- Pharmazeutische Produktion, Medizin- & Gesundheitsbedarf
Listed in a source registry
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)
- Medicines imported into the EU must come from a site holding an EU GMP certificate, and the importer needs a manufacturing/import authorisation. European Medicines Agency (GMP)