EU → North America Device Access

Calbe Chemie GmbH

DE-MF-000014738 · Germany · Calbe

Calbe Chemie GmbH is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa8

Most frequent device types declared: T 32 X-Ray Developer, UNIROLL-D, UNIROLL-F, Unimatic D Automatic Developer.

Devices declared under this manufacturer

Catalogue references include 10120, 10122, 10511, 10571, T 32 10042, UNIROLL-D.

European nomenclature codes declared: Z11070785.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED8
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 GTIN8
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. Calbe Chemie GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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