EU → North America Device Access

WILAmed GmbH

DE-MF-000007207 · Germany · Kammerstein

WILAmed GmbH is registered in the European database on medical devices as a manufacturer, with 18 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa18

Most frequent device types declared: Headgear.

Among these devices, 3 are declared active, 1 with a measuring function.

Devices declared under this manufacturer

Showing 12 of 18 declared devices.

Catalogue references include 100909, 201001, 2701021, 2701661, 271072, 300050.

European nomenclature codes declared: R030180, R060280, R020107, R020202, R02010401, R0301010202.

United States market access

FDA establishment registerRegistered with FDA
Matched entryWILAMED GMBH (DE) · FDA 9615827
Devices in EUDAMED18
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN18
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryWILAMED GMBH

What it holds in Canada

Licences on record3
Currently active0
Class 2 devices3
First licensed2023-12-21

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

Licensed under: BREATHING TUBE HEATED WITH POWER SUPPLY UNIT, CLEARLINE UNHEATED BREATHING SET FOR MECHANICA, BREATHING SET UNHEATED.

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

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