SteriPack
Разработка, производство медицинского оборудования и фармацевтической упаковочной продукции.
SteriPack занимается разработкой, производством и фармацевтической упаковочной продукцией медицинского оборудования на своем предприятии в Маллингаре. Компания поставляет системы здравоохранения, лаборатории, OEM-партнерам или регулируемым экспортным клиентам на перечисленных основных рынках.
- Type
- brand seeking distribution
- Location
- Mullingar, Ireland
- Founded
- 1994
- Website
- steripack.com
- Categories
- Медицинские товары и расходники, Упаковка и полиграфия
- Markets
- Ирландия, Соединенные Штаты, Великобритания, Германия
Verified facts
- debarment-clear (green), checked 2026-08-12 OpenSanctions
- sanctions-clear (green), checked 2026-08-12 OpenSanctions
Claimed certifications
- ISO 13485, Medical Devices Quality IAF CertSearch
- CE Marking EU NANDO (notified bodies)
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)
- If the goods are paper, board or printed products, EU imports fall under the Deforestation Regulation (EUDR) due-diligence regime; packaging machinery itself does not. European Commission (EUDR)
- No public registry exists for certificates of this kind in this sector: conformity is declared by the manufacturer. European Commission: CE marking, manufacturer's conformity assessment