Masimo
Устройства для мониторинга пациентов, пульсоксиметрии и автоматизации больниц.
Masimo производит устройства для мониторинга пациентов, пульсоксиметрии и автоматизации больниц на своих предприятиях в Ирвине. Компания поставляет системы здравоохранения, лаборатории, OEM-партнерам или регулируемым экспортным клиентам на перечисленных основных рынках.
- Type
- brand seeking distribution
- Location
- Irvine, United States
- Founded
- 1989
- Website
- masimo.com
- Categories
- Медицинские товары и расходники, Носимые устройства
- Markets
- Соединенные Штаты, Германия, Япония, Австралия
Verified facts
- domain-registered (green), checked 2026-08-07 Domain registry record
- facility-registered (green), checked 2026-08-07 US EPA Facility Registry Service (national combined file)
- registered-manufacturer (green), checked 2026-08-21 ALIMS (Medicines and Medical Devices Agency of Serbia), register of medical-device manufacturers
- lei-active (green), checked 2026-08-23 GLEIF global LEI register (golden copy)
- places-goods-on-market (green), checked 2026-08-30 Registre national des producteurs (ADEME/SYDEREP), France
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)
- Electronics for the EU need CE marking incl. RoHS substance limits, and producers must register for WEEE take-back in each member state of sale. European Commission (CE)
- Electronics for the US market need FCC equipment authorization under 47 CFR Part 15, which covers unintentional radiators such as switch-mode power supplies, not only radio devices. US FCC (Part 15)