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P.T.S. Haplast - Janusz Hahn

PL-MF-000023591 · Poland · Wrocław

P.T.S. Haplast - Janusz Hahn is registered in the European database on medical devices as a manufacturer, with 9 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa9

Among these devices, 9 are declared with a measuring function.

Devices declared under this manufacturer

Catalogue references include D01, D03, D05, S01, S02, S03.

European nomenclature codes declared: V0380.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED9
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 GTIN9
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. P.T.S. Haplast - Janusz Hahn was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
TNP/MDR/0040/1427/2025issued2030-09-09
TNP/MDR/0001/1427/2022issued2025-09-12

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