EU → North America Device Access

SURGIWELL GmbH

DE-MF-000005918 · Germany · Tuttlingen

SURGIWELL GmbH is registered in the European database on medical devices as a manufacturer, with 88 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa88

Most frequent device types declared: Chirurgielöffel, Elevatorium, Häkchen, sonstige, Nadel, sonstige, Schere, sonstige (Mikro-Scheren).

Among these devices, 88 are declared reusable.

Devices declared under this manufacturer

Showing 12 of 88 declared devices.

Catalogue references include 11-035-12, 15-060-14, 15-150-08, 18-610-25, 22-071-17, 31-250-01.

European nomenclature codes declared: L0914, L010413, L03140104, L06060199, L149007, L01040602.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED88
Country of registrationGermany

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

Device-level evidence

Devices with a numeric GTIN88
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. SURGIWELL GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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