EU → North America Device Access

Medical Respiratory Devices S.L

ES-MF-000000824 · Spain · Coslada

Medical Respiratory Devices S.L is registered in the European database on medical devices as a manufacturer, with 21 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa21

Most frequent device types declared: Neumofilt Ergo, Neumofilt Ergo Pack Confort, Neumofilt Ergo Pack Confort Plus, Neumofilt Ergo Pack Plus.

Devices declared under this manufacturer

Showing 12 of 21 declared devices.

Catalogue references include 1533N03, 1533N03M, 1535, 1535M, 1535N03M, 1536M.

European nomenclature codes declared: R049001, Z12150185.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED21
Country of registrationSpain

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN21
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryMEDICAL RESPIRATORY DEVICES S.L.

What it holds in Canada

Licences on record1
Currently active0
Class 2 devices1
First licensed2014-02-27

Licence types: Device Family (1).

Licensed under: NEUMOFILT BACTERIAL/VIRAL FILTERS.

North American profile: Canada only. Medical Respiratory Devices S.L holds a Canadian licence but was not found in the U.S. register.

Other manufacturers in Spain

All Spain manufacturers →