EU → North America Device Access

Surgical Instruments Belgium

BE-MF-000029624 · Belgium · Gembloux

Surgical Instruments Belgium is registered in the European database on medical devices as a manufacturer, with 1 289 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa1 289

Most frequent device types declared: DERF NEEDLE HOLDER, TCI, 11.5 CM, TITANIUM.

Among these devices, 1 289 are declared reusable.

Catalogue references include 16-0-0510-0015, 18-2-0767-0123, 45-2-0046-2121, ES003-325, ES020-020, ES029-218.

European nomenclature codes declared: L010403, L0205, L031306, L031310, L07080199, L03140102.

United States market access

FDA establishment registerRegistered with FDA
Matched entrySURGICAL INSTRUMENTS BELGIUM SA (BE) · FDA 3003675041
Devices in EUDAMED1 289
Country of registrationBelgium

Device-level evidence

Devices with a numeric GTIN1 289
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: United States only. Surgical Instruments Belgium is registered in the United States but was not found in the Canadian register.

Other manufacturers in Belgium

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