EU → North America Device Access

Orgaterm Produktions- und Warenvertriebsgesellschaft mbH0

DE-MF-000035762 · Germany · Nordkirchen

Orgaterm Produktions- und Warenvertriebsgesellschaft mbH0 is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa7

Most frequent device types declared: 7007/7029P, Augenkompresse/Stirnband, Autositzbezug / Autorückenstütze, Forte-Ronde / Forte-Rechteckig, Hand/Handgelenk/Arm/Ellenbogen/Schulter.

Devices declared under this manufacturer

Catalogue references include 7007 / 7029 P, MA-7001RB / MA-7010NB / MA-7013NB / MA-7005AK / MA-7035UL, MA-7002KB / MA-7039FG / MA-7052US / MA-7053OS, MA-7003AB / MA-7029P / MA-7033HGB / MA-7034EB / MA-7011SB, MA-7004STB/MA-7049GHA, MA-7009SR/MA-7008SE.

European nomenclature codes declared: Z120606.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED7
Country of registrationGermany

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

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: Neither register. Orgaterm Produktions- und Warenvertriebsgesellschaft mbH0 was not found in either the U.S. or the Canadian register.

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