Masimo

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)

Check independently

• Sanctions and watchlists (OpenSanctions)