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HAGMED Sp. z o.o. Sp. komandytowa

PL-MF-000021862 · Poland · RAWA MAZOWIECKA

HAGMED Sp. z o.o. Sp. komandytowa is registered in the European database on medical devices as a manufacturer, with 12 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class I12

Among these devices, 12 are declared sterile.

Devices declared under this manufacturer

Catalogue references include EA7QB252U4AT, EA7QL252U3I8AT, EA7QL252U4AT, EA7QL252U4I8AT, EA7QM252U3I8AT, EA7QM252U4AT.

European nomenclature codes declared: C020301.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED12
Country of registrationPoland

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

Device-level evidence

Devices with a numeric GTIN12
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. HAGMED Sp. z o.o. Sp. komandytowa was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
1434-MDR-020/2025issued2030-10-09
1434-MDR-019/2025issued2030-10-09

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