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Lubelskie Zakłady Farmaceutyczne "POLFA" Spółka Akcyjna

PL-MF-000015608 · Poland · Lublin

Lubelskie Zakłady Farmaceutyczne "POLFA" Spółka Akcyjna is registered in the European database on medical devices as a manufacturer, with 40 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa40

Among these devices, 36 are declared with a measuring function.

Devices declared under this manufacturer

Showing 12 of 40 declared devices.

Catalogue references include 194400, QDOZ-0002-000, QDOZ-0004-000, QDOZ-0008-000, QKIE-0002-000, QKIE-0004-000.

European nomenclature codes declared: V0380, U0899.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED40
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 GTIN40
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. Lubelskie Zakłady Farmaceutyczne "POLFA" Spółka Akcyjna was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
TNP/MDR/0024/0052/2024issued2027-09-05

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