STERIS Laboratories Inc
Услуги по контрактной стерилизации и лабораторным испытаниям | СТЕРИС АСТ
STERIS AST предоставляет услуги по контрактной стерилизации, лабораторным испытаниям, а также испытаниям продукции и упаковки производителям медицинского оборудования и фармацевтических препаратов.
- Type
- Manufacturer
- Location
- Malaysia
- Website
- https://steris-labs.com
- Categories
- Фармацевтическое производство, Медицинские товары и расходники, Упаковка и полиграфия
Verified facts
- domain-registered (green), checked 2026-08-09 Domain registry record
- sanctions-clear (green), checked 2026-08-09 OpenSanctions
- debarment-clear (green), checked 2026-08-09 OpenSanctions
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)
- Paper and printed products imported into the EU fall under the Deforestation Regulation (EUDR) due-diligence regime. European Commission (EUDR)
- 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)