Natus Medical Incorporated
Neurology and newborn care diagnostics for hospitals worldwide.
Natus Medical is a manufacturer of medical devices and services for the diagnosis and treatment of neurological disorders, newborn care, and hearing impairment. Product lines include EEG monitoring systems, newborn brain monitoring equipment, otoacoustic emission screening devices, and jaundice phototherapy systems. Natus serves pediatric and adult neurology departments across more than 100 countries through direct sales and distributor networks.
- Type
- Manufacturer
- Location
- Middleton, WI, United States
- Founded
- 1987
- Website
- natus.com
- Categories
- Medical & Healthcare Supplies, Consumer Electronics
- Markets
- United States, Germany, United Kingdom, Australia, Japan, Brazil
Verified facts
- corporate-mail-on-domain (green), checked 2026-08-09 Mail server of the company domain
- manufacturing-practice-certified (green), checked 2026-08-21 ANVISA (Brazilian Health Regulatory Agency), public register of Good Manufacturing Practice certificates (CBPF)
- registered-manufacturer (green), checked 2026-08-21 ALIMS (Medicines and Medical Devices Agency of Serbia), register of medical-device manufacturers
- domain-registered (green), checked 2026-08-09 Domain registry record
- lei-lapsed (amber), checked 2026-08-23 GLEIF global LEI register (golden copy)
- sanctions-clear (green), checked 2026-08-09 OpenSanctions
- fda-registered (green), checked 2026-08-09 FDA
- debarment-clear (green), checked 2026-08-09 OpenSanctions
Claimed certifications
- ISO 13485, Medical Devices Quality IAF CertSearch
- CE Marking EU NANDO (notified bodies)
- 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)