EU → North America 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.

Devices declared under this manufacturer

Showing 12 of 132 declared devices.

Catalogue references include 1021546, 1021705, 1021713E, 1021716E, 1021722E, 1021732.

European nomenclature codes declared: A080102, A088099.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED132
Country of registrationGermany

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN132
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: Neither register. Hegewald Medizinprodukte GmbH was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
2608GB448230509issued2027-06-20

Other manufacturers in Germany

All Germany manufacturers →