Brainlab
Surgical navigation, radiotherapy and digital operating room systems.
Brainlab manufactures surgical navigation, radiotherapy and digital operating room systems from its Munich operations. The company supplies healthcare systems, laboratories, OEM partners or regulated export customers across its listed primary markets.
- Type
- Manufacturer
- Location
- Munich, Germany
- Founded
- 1989
- Website
- brainlab.com
- Categories
- Medical & Healthcare Supplies, Consumer Electronics
- Markets
- Germany, United States, Japan, China
Verified facts
- domain-registered (green), checked 2026-08-02 Domain registry record
- 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)
- sanctions-clear (green), checked 2026-08-15 OpenSanctions
- debarment-clear (green), checked 2026-08-15 OpenSanctions
Claimed certifications
- ISO 13485, Medical Devices Quality IAF CertSearch
- CE Marking EU NANDO (notified bodies)
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)