EU → US Device Access

Didactic

FR-MF-000000176 · France · Saint-Jean-de-la-Neuville

Didactic is registered in the European database on medical devices as a manufacturer, with 146 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa146

Most frequent device types declared: 3-way IV Infusion set, 1-way extension lines : PMFFL-F, 3-way extension lines : PR3LVM-LFBPAF, 1-way extension lines : PMFML-F, 3-way extension lines : PR3LVF-LFBPAF.

Among these devices, 44 are declared sterile.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED146
Country of registrationFrance
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

Notified body certificates

CertificateStatusExpiry
ECM25MDR014withdrawn2030-07-28
C744010issued2031-04-27

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