EU → North America Device Access

Noris Medical GmbH

DE-MF-000022591 · Germany · Oberursel

Noris Medical GmbH is registered in the European database on medical devices as a manufacturer, with 359 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa359

Among these devices, 186 are declared reusable.

Devices declared under this manufacturer

Showing 12 of 359 declared devices.

Catalogue references include NG-B2230, NG-X3001, NG-X7009, NGCD3027, NGCD3028, NGCX2213.

European nomenclature codes declared: Q010399, Q010280, Q010207, Q019005, S010401, Q010207,Q010280.

United States market access

FDA establishment registerRegistered with FDA
Matched entryNORIS MEDICAL LTD. (IL) · FDA 3011390931
Devices in EUDAMED359
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN359
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryNORIS MEDICAL LTD.

What it holds in Canada

Licences on record6
Currently active0
Class 3 devices6
First licensed2018-09-05

Licence types: System (6).

Licensed under: TUFF DENTAL IMPLANT SYSTEM, ZYGOMATIC DENTAL IMPLANT SYSTEM, TUFF TT DENTAL IMPLANT SYSTEM, MBI DENTAL IMPLANT SYSTEM, CORTICAL DENTAL IMPLANT SYSTEM, MONO DENTAL IMPLANT SYSTEM.

North American profile: Both markets. Noris Medical GmbH is registered in both the United States and Canada.

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