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Telemis S.A.

Active in EUDAMED

Belgiumfrom SRN EUDAMED SRN BE-MF-000000108

Devices
1
Registrations
EUDAMED

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor

What Telemis S.A. makes

Telemis S.A. develops medical imaging software platforms for hospitals and clinics, including Picture Archiving and Communication Systems (PACS), Medical Archiving and Communication Systems (MACS), and Virtual Networked Archives (VNA). These solutions enable secure storage, viewing, sharing, and analysis of medical images across radiology, pathology, cardiology, and other specialties. The platform also supports teleradiology services and integrates with healthcare business-intelligence tools.

The company’s products fall under EU Class IIa medical devices and are listed in the EUDAMED registry. Telemis S.A. is based in Belgium.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue1

Newest first, rows 1-1 of 1

  • Telemis Ref Telemis Medical V4.YY.ZZ

    Active Regimes: CE MDD 510(k) Registry: EUDAMED510(k) Class:IIa

Company details

EUDAMED SRN
BE-MF-000000108
EU VAT number
BE 0465 769 650
EUDAMED status
Active
EUDAMED registered name
Telemis S.A.
EUDAMED abbreviated name
Telemis
Registered address
2, Avenue Athena, 1348, Louvain-la-Neuve, Belgium
Phone
+3210480011
PRRC contact
Jean-Claude Spelte(public in EUDAMED)

From the company website

Read 18 Oct 2026

Belgian medical-imaging software company. Its platform (PACS, MACS, VNA) lets hospitals and clinics store, view, share and analyse medical images across radiology, pathology, cardiology and other specialties, plus teleradiology and the Intuitus healthcare business-intelligence suite.

From the manufacturer's own website. Source

Frequently asked questions

How many devices does Telemis S.A. have in the registry?

The registry currently lists 1 device for Telemis S.A.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Telemis S.A.'s devices?

Among its 1 most recently registered device, Telemis S.A. has devices listed in EUDAMED (1 device) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Telemis S.A.'s devices fall under?

Among its 1 most recently registered device, the classes recorded for Telemis S.A.'s devices are Class IIa. Each device page shows its own class and authorisation.

What are the newest devices from Telemis S.A. in the registry?

The most recently registered devices listed for Telemis S.A. include Telemis.

Generated automatically from registry data and not verified by a human reviewer.