EU → North America Device Access

Erkodent Erich Kopp GmbH

DE-MF-000006243 · Germany · Pfalzgrafenweiler

Erkodent Erich Kopp GmbH is registered in the European database on medical devices as a manufacturer, with 43 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa43

Most frequent device types declared: Erkocryl, Erkodur, Erkodur-al, Erkoflex, Erkolen.

Devices declared under this manufacturer

Showing 12 of 43 declared devices.

Catalogue references include 522006, 523008, 523010, 524108, 529508, 541220.

European nomenclature codes declared: Q010699, Q01020199.

United States market access

FDA establishment registerRegistered with FDA
Matched entryERKODENT ERICH KOPP GMBH (DE) · FDA 8010662
Devices in EUDAMED43
Country of registrationGermany

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: United States only. Erkodent Erich Kopp GmbH is registered in the United States but was not found in the Canadian register.

Notified body certificates

CertificateStatusExpiry
HZ 1073124-1issued2025-04-29
HZ 1073124-1reissued2030-04-29

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