EU → North America Device Access

STERIWUND spol. s r.o.

CZ-MF-000036963 · Czechia · Havířov

STERIWUND spol. s r.o. is registered in the European database on medical devices as a manufacturer, with 557 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa557

Among these devices, 228 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 557 declared devices.

Catalogue references include 0305/S, 0461, 0628, 0635, 0740, 0957/100.

European nomenclature codes declared: M0201050101, M030101, T010201, T01020201, M0599, M040499.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED557
Country of registrationCzechia

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

Device-level evidence

Devices with a numeric GTIN557
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. STERIWUND spol. s r.o. was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
26 0022 QR/NBissued2031-02-11

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