EU → North America Device Access

OCULUS Optikgeräte GmbH

DE-MF-000012227 · Germany · Wetzlar

OCULUS Optikgeräte GmbH is registered in the European database on medical devices as a manufacturer, with 196 devices declared. It has a similarly named entry in the FDA register that we have not verified.

What this manufacturer declares

Class IIa196

Among these devices, 72 are declared active, 10 with a measuring function.

Devices declared under this manufacturer

Showing 12 of 196 declared devices.

Catalogue references include 10023559, 10023561, 10023570, 10033269, 331901, 33193.

European nomenclature codes declared: Z12120180, Z12129001, Z1212012099, Z12129099, Z1212012080, Z12120123.

United States market access

FDA establishment registerSimilar name found — unverified
Matched entryOCULUS OPTIKGERATE GMBH (DE) · FDA 9611269
Devices in EUDAMED196
Country of registrationGermany

⚠️ A similar name exists; we do not assert it is the same company — why.

Device-level evidence

Devices with a numeric GTIN196
Found in the U.S. device database105
Share53.6 %

Canadian market access

Health Canada licence listingSimilar name found — unverified
Matched entryOCULUS OPTIKGERAETE GMBH

⚠️ A similar name exists; unverified — why.

What it holds in Canada

Licences on record18
Currently active0
Class 2 devices18
First licensed2005-10-06

Licence types: Single Device (14), Device Family (4).

Licensed under: PENTACAM EYE SCANNER, AUTOMATED PERIMETER, OCULUS KERATOGRAPH, CORVIS ST, EASYGRAPH, C-QUANT.

Other manufacturers in Germany

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