Mediso Medical Imaging Systems Kft.
Hungarian nuclear-medicine and preclinical imaging-system manufacturer.
Mediso manufactures SPECT, PET, CT, MRI, and multimodal medical imaging systems in Hungary. Founded in 1990, the company supplies hospitals, research institutions, and medical-device distributors worldwide.
- Type
- Manufacturer
- Location
- Budapest, Hungary
- Founded
- 1990
- Website
- mediso.com
- Categories
- Medical & Healthcare Supplies, Consumer Electronics
- Markets
- Hungary, Germany, United States, Japan
Verified facts
- corporate-mail-on-domain (green), checked 2026-08-09 Mail server of the company domain
- domain-registered (green), checked 2026-08-09 Domain registry record
- public-contract-awarded (green), checked 2026-08-02 TED, EU public procurement bulletin Here the award carries someone else's check: in the EU and the EEA a public buyer must exclude bidders convicted of fraud, corruption or money laundering, and those found by a final decision to owe taxes or social contributions. Directive 2014/24/EU, Article 57 (exclusion grounds)
- sanctions-clear (green), checked 2026-08-09 OpenSanctions
- debarment-clear (green), checked 2026-08-09 OpenSanctions
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)