EU → North America Device Access

CJ-Optik GmbH & Co. KG

DE-MF-000009627 · Germany · Asslar-Werdorf

CJ-Optik GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 470 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa470

Among these devices, 334 are declared active.

Devices declared under this manufacturer

Showing 12 of 470 declared devices.

Catalogue references include 102-1200-0010, 102-403-0000, 102-600-0000, 103-3100-0030, 210-000-0030, 605-000-0032.

European nomenclature codes declared: Z1201118099, Z12011101.

United States market access

FDA establishment registerRegistered with FDA
Matched entryCJ-OPTIK GMBH & CO. KG (DE) · FDA 3016017660
Devices in EUDAMED470
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN470
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: United States only. CJ-Optik GmbH & Co. KG is registered in the United States but was not found in the Canadian register.

Other manufacturers in Germany

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