EU → North America Device Access

Ortopedia y Cirugía, S.L.

ES-MF-000016977 · Spain · Sant Fruitós de Bages

Ortopedia y Cirugía, S.L. is registered in the European database on medical devices as a manufacturer, with 149 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa149

Among these devices, 85 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 149 declared devices.

Catalogue references include 339N, 356N, 360-0302, 4515008, 754500P, 754512P.

European nomenclature codes declared: M0201020101, M0201020102, M030499, M0201030101, M0201020201, M0201030201.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED149
Country of registrationSpain

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

Device-level evidence

Devices with a numeric GTIN149
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. Ortopedia y Cirugía, S.L. was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
2024 PR 0016issued2029-02-18

Other manufacturers in Spain

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