Ensera, a trading name of SteriPack Medical Poland Sp. z o.o
Ensera are the global design and contract manufacturing experts for industry-leading medical device and pharmaceutical businesses
Ensera are the global design and contract manufacturing experts for industry-leading medical device and pharmaceutical businesses.
- Type
- Manufacturer
- Location
- Jelcz-Laskowice, Poland
- Website
- http://steripackgroup.com/
- Categories
- Pharmaceutical Manufacturing, Medical & Healthcare Supplies
Listed in a source registry
Verified facts
- corporate-mail-on-domain (green), checked 2026-08-09 Mail server of the company domain
- domain-registered (green), checked 2026-08-09 Domain registry record
- debarment-clear (green), checked 2026-08-09 OpenSanctions
- sanctions-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)
- 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)