EU → North America Device Access

Theo Manufacturing B.V.

NL-MF-000006692 · Netherlands · Maastricht

Theo Manufacturing B.V. is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class I2
Class IIa3

Most frequent device types declared: L Mesitran Ointment 50g.

Devices declared under this manufacturer

Catalogue references include 1005.01, 1029.01, 104.01, 105.01, 174702.

European nomenclature codes declared: M9002, M040499.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED5
Country of registrationNetherlands

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

Device-level evidence

Devices with a numeric GTIN5
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryTHEO MANUFACTURING B.V.

North American profile: Canada only. Theo Manufacturing B.V. holds a Canadian licence but was not found in the U.S. register.

Other manufacturers in Netherlands

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