EU → North America Device Access

Sigma Laborzentrifugen GmbH

DE-MF-000009414 · Germany · Osterode am Harz

Sigma Laborzentrifugen GmbH is registered in the European database on medical devices as a manufacturer, with 25 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa3

Among these devices, 3 are declared active.

Devices declared under this manufacturer

Showing 12 of 25 declared devices.

Catalogue references include 100008, 100012, 100029, 100030, 100049, 10054.

European nomenclature codes declared: W02069005, W02069003.

United States market access

FDA establishment registerRegistered with FDA
Matched entrySIGMA LABORZENTRIFUGEN GMBH (DE) · FDA 8010707
Devices in EUDAMED25
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN25
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. Sigma Laborzentrifugen GmbH is registered in the United States but was not found in the Canadian register.

Other manufacturers in Germany

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