EU → US Device Access

Hegewald Medizinprodukte GmbH

DE-MF-000006219 · Germany · Lichtenberg

Hegewald Medizinprodukte GmbH is registered in the European database on medical devices as a manufacturer, with 132 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa132

Most frequent device types declared: Sterile Infusionsmischbeutel (Sterile Mixing and Infusion bags), Sterile Schlauchsysteme (Sterile Tube Systems).

Among these devices, 132 are declared sterile, 119 with a measuring function.

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 EUDAMED132
Country of registrationGermany
⚠️ 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
2608GB448230509issued2027-06-20

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