EU → North America Device Access

Tecnoclínic SA

ES-MF-000000632 · Spain · Sabadell (Barcelona)

Tecnoclínic SA is registered in the European database on medical devices as a manufacturer, with 84 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa84

Most frequent device types declared: 29420 - A0104, 29440 - A0304, A0318, A0349, A0369.

Among these devices, 21 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 84 declared devices.

Catalogue references include 28688 - 800160, 29416-800154, 494302-801113, 651761, 801043, A0391.

European nomenclature codes declared: A06030301, A0680.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED84
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 GTIN84
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. Tecnoclínic SA was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
CGP000124issued2029-04-15

Other manufacturers in Spain

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