EU → North America Device Access

Spierings Orthopaedics B.V.

NL-MF-000023199 · Netherlands · Nijmegen

Spierings Orthopaedics B.V. is registered in the European database on medical devices as a manufacturer, with 250 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa239
Class I5
Class IIb6

Most frequent device types declared: Noviomagus BIG Instrumentation, Noviomagus Cup Resector, Noviomagus Femoral Head Reamer Set, Noviomagus Revision Mesh Acetabular Rim Small, Noviomagus Revision Mesh Universal Flat.

Among these devices, 11 are declared sterile, 11 implantable, 128 reusable.

Devices declared under this manufacturer

Showing 12 of 250 declared devices.

Catalogue references include NCR-1707-06, NCR-1707-50F-RU, NCR-1707-60S-RU, NCR-1707-68S/RU, NCR-1901-36, NCR-1901-58.

European nomenclature codes declared: L091101, L0999, P09088002, P09088099.

United States market access

FDA establishment registerRegistered with FDA
Matched entrySPIERINGS ORTHOPAEDICS B.V. (NL) · FDA 3002736229
Devices in EUDAMED250
Country of registrationNetherlands

Device-level evidence

Devices with a numeric GTIN250
Found in the U.S. device database55
Share22.0 %

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: United States only. Spierings Orthopaedics B.V. is registered in the United States but was not found in the Canadian register.

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