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Is Trium CTG Online certified as a medical device?

Trium CTG Online by Trium Analysis Online GmbH is listed in EUDAMED as a CE class IIb medical device. No notified body certificate is visible in EUDAMED yet; ask the maker for it (devices still under the older MDD rules often have none listed). We found no FDA authorisation.

At a glance

Product	Trium CTG Online
Maker	Trium Analysis Online GmbH
Care area	Women's health & fertility
What it does	Software for central monitoring and automated analysis of fetal heart rate (CTG) recordings
FDA	No FDA authorisation found
EU (CE)	Class IIb
EU certificate	Not visible in EUDAMED yet (checked 18 October 2026)
Website	trium.de
Status	CE verified
Last checked	6 October 2026

Certification status can change. Always confirm in the official register before relying on it: the FDA databases, EUDAMED or the BfArM DiGA directory.

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