EU → North America Device Access

Moria S.A.

FR-MF-000000336 · France · BOURBON L'ARCHAMBAULT

Moria S.A. is registered in the European database on medical devices as a manufacturer, with 774 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa774

Most frequent device types declared: 1141, 17200D600, 17201D700, 17210, 17223x10.

Among these devices, 261 are declared sterile, 509 reusable, 1 active, 2 with a measuring function.

Devices declared under this manufacturer

Showing 12 of 774 declared devices.

Catalogue references include 17202D725, 17210, 17301x5, 19074, 20037/1.8, 20057.

European nomenclature codes declared: L170299, Q0299, Q020201, Q020299, Z1212020599, Z1212020585.

United States market access

FDA establishment registerRegistered with FDA
Matched entryMORIA S.A. (FR) · FDA 9615659
Devices in EUDAMED774
Country of registrationFrance

Device-level evidence

Devices with a numeric GTIN773
Found in the U.S. device database520
Share67.3 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryMORIA S.A.

What it holds in Canada

Licences on record11
Currently active0
Class 2 devices11
First licensed2005-03-02

Licence types: System (8), Device Family (2), Device Group (1).

Licensed under: EVOLUTION 3 SYSTEM, EPI-KERATOME SYSTEM, ONE USE PLUS SYSTEM, EVOLUTION 3E SYSTEM, ONE SYSTEM, M2 SYSTEM.

North American profile: Both markets. Moria S.A. is registered in both the United States and Canada.

Notified body certificates

CertificateStatusExpiry
39713supplemented2029-05-02

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