EU → North America Device Access

Servo-Dental GmbH & Co.KG

DE-MF-000006522 · Germany · Hagen

Servo-Dental GmbH & Co.KG is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa4
Class IIb3

Among these devices, 1 are declared sterile, 4 implantable, 2 reusable.

Devices declared under this manufacturer

Catalogue references include 1000, 1203321TRA, 1406001TRA, 200203TRA, 3121, 33010TX.

European nomenclature codes declared: P01020180, Q010280, P01020101.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED7
Country of registrationGermany

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

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. Servo-Dental GmbH & Co.KG was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
44911220492issued2031-04-06

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