EU → US Device Access

Deltamedica GmbH

DE-MF-000006440 · Germany · Reutlingen

Deltamedica GmbH is registered in the European database on medical devices as a manufacturer, with 11 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class IIa10
other1

Most frequent device types declared: 3000 ml, BSS 20 x 500mL Plastic Bottle, 5000 ml, 3000mL, 5000 mL.

Among these devices, 11 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 registerSimilar name found — unverified
Matched entryDELTAMED GMBH (DE) · FDA 3002789526
Devices in EUDAMED11
Country of registrationGermany
⚠️ A similar name exists in the FDA register. We do not assert that it is the same company — the two registers share no common identifier, and a name alone is not proof. This entry needs a human check.

Other manufacturers in Germany

All Germany manufacturers →