EU → North America Device Access

Leica Microsystems CMS GmbH

DE-MF-000019760 · Germany · Wetzlar

Leica Microsystems CMS GmbH is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Most frequent device types declared: DM1000, DM2000, DM2500.

Devices declared under this manufacturer

Catalogue references include 11888133, 11888138, 11888139, 11888842, 11888843.

European nomenclature codes declared: W0202050303.

United States market access

FDA establishment registerRegistered with FDA
Matched entryLEICA MICROSYSTEMS CMS GMBH (DE) · FDA 3003893952
Devices in EUDAMED5
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN5
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingSimilar name found — unverified
Matched entryLEICA MICROSYSTEMS NC, INC.

⚠️ A similar name exists; unverified — why.

What it holds in Canada

Licences on record1
Currently active0
Class 2 devices1
First licensed2023-10-16

Licence types: System (1).

Licensed under: ENFOCUS 2300 INTEGRATED OCT SYSTEM.

Other manufacturers in Germany

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