Masimo
환자 모니터링, 맥박 산소 측정 및 병원 자동화 장치.
Masimo는 Irvine 사업장에서 환자 모니터링, 맥박 산소 측정 및 병원 자동화 장치를 제조합니다. 이 회사는 나열된 주요 시장 전반에 걸쳐 의료 시스템, 실험실, OEM 파트너 또는 규제 수출 고객에게 제품을 공급합니다.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer
- Location
- Irvine, United States
- Founded
- 1989
- Website
- masimo.com
- Categories
- 의료 및 건강 관리 용품, 웨어러블 및 개인용 기기
- Markets
- 미국, 독일, 일본, 오스트레일리아
What is established and what is not
No facet of this company has been investigated yet. The facts below are collected records, not an assessment: nothing here confirms manufacturing, ownership or trading status beyond what each record literally says.
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 2026-09-07 GLEIF global LEI register (golden copy)
- places-goods-on-market (green), checked 2026-09-07 Registre national des producteurs (ADEME/SYDEREP), France
- registry-id-verified (green), checked 2026-09-10 GLEIF Global LEI record
Claimed certifications, not confirmed by us
- 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)