EU → North America Device Access

Zakład Techniki Medycznej "Tech-Med" Sp. z o.o.

PL-MF-000009262 · Poland · Bydgoszcz

Zakład Techniki Medycznej "Tech-Med" Sp. z o.o. is registered in the European database on medical devices as a manufacturer, with 747 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa745
Class IIb2

Most frequent device types declared: AP, C, PAK, PT, SK.

Among these devices, 2 are declared active.

Devices declared under this manufacturer

Showing 12 of 747 declared devices.

Catalogue references include AP3, C-02-66, C-03-66, PT1-01-U, SMP-04, SR1.

European nomenclature codes declared: V0899, V9099, V080603, V080202, Z11059099, L99.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED747
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 GTIN747
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. Zakład Techniki Medycznej "Tech-Med" Sp. z o.o. was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
TNP/MDR/0044/1127/2025supplemented2028-12-07
TNP/MDR/0004/1127/2022amended2025-12-07

Other manufacturers in Poland

All Poland manufacturers →