EU → North America Device Access

SPRONKEN ORTHOPEDIE

BE-MF-000003430 · Belgium · Genk

SPRONKEN ORTHOPEDIE is registered in the European database on medical devices as a manufacturer, with 19 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa19

Catalogue references include NF-KAAKBANDAGE-COLD, NF-KNIEBANDAGE-ZWART, NF-SHOULDERBAND-COLD, NI-HEUPSPICA-L-S, NI-HEUPSPICA-L-XL, NI-HEUPSPICA-R-XXL.

European nomenclature codes declared: Y061215, Y061209, M030501, Y060621, M0399.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED19
Country of registrationBelgium

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

Device-level evidence

Devices with a numeric GTIN19
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. SPRONKEN ORTHOPEDIE was not found in either the U.S. or the Canadian register.

Other manufacturers in Belgium

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