Hologic
Товары для диагностики женского здоровья, визуализации и хирургии.
Hologic производит диагностические, визуальные и хирургические продукты для женского здоровья на своих предприятиях в Мальборо. Компания поставляет системы здравоохранения, лаборатории, OEM-партнерам или регулируемым экспортным клиентам на перечисленных основных рынках.
- Type
- brand seeking distribution
- Location
- Marlborough, United States
- Founded
- 1985
- Website
- hologic.com
- Categories
- Медицинские товары и расходники
- Markets
- Соединенные Штаты, Германия, Япония, Австралия
Verified facts
- corporate-mail-on-domain (green), checked 2026-08-08 Mail server of the company domain
- domain-registered (green), checked 2026-08-08 Domain registry record
- debarment-clear (green), checked 2026-08-08 OpenSanctions
- sanctions-clear (green), checked 2026-08-08 OpenSanctions
- fda-registered (green), checked 2026-08-08 FDA
- registered-manufacturer (green), checked 2026-08-21 ALIMS (Medicines and Medical Devices Agency of Serbia), register of medical-device manufacturers
- lei-lapsed (amber), checked 2026-08-23 GLEIF global LEI register (golden copy)
- facility-registered (green), checked 2026-08-07 US EPA Facility Registry Service (national combined file)
Claimed certifications
- ISO 13485, Medical Devices Quality IAF CertSearch
- FDA Registered FDA Establishment Registration
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)