EU → North America Device Access

SanaPro Dental GmbH

DE-MF-000005416 · Germany · Bremerhaven

SanaPro Dental GmbH is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa5

Among these devices, 4 are declared implantable.

Catalogue references include 0025SP, 0886SP, EXO513, NORCEMC&B, NORMOSILEXTRACLEAR.

European nomenclature codes declared: Q01010103, Q01010106, Q01020605, Q01020102, Q01010104.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED5
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. SanaPro Dental GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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