Hiper Cast GmbH
Hiper Cast GmbH CPP film producer located in Austria specialised in retort film, LTS film for monomaterial structure 100% PP, film from 25µ to 300µ serving medical, pharma, technical and food
- Type
- Manufacturer
- Location
- Hermagor, Austria
- Website
- hipercast.at
- Categories
- Pharmaceutical Manufacturing, Medical & Healthcare Supplies
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)