EU → North America Device Access

HumanTech Spine GmbH

DE-MF-000010596 · Germany · Steinenbronn

HumanTech Spine GmbH is registered in the European database on medical devices as a manufacturer, with 86 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa86

Among these devices, 1 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 86 declared devices.

Catalogue references include 1001010406, 1005010100, 1006010140, 1006010511, 1016200000, 2200010201.

European nomenclature codes declared: S010401, L99, Y181806, P099002.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED86
Country of registrationGermany

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

Device-level evidence

Devices with a numeric GTIN86
Found in the U.S. device database0
Share0.0 %

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. HumanTech Spine GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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