EU → North America Device Access

TRICOMED S.A.

PL-MF-000002483 · Poland · Łódź

TRICOMED S.A. is registered in the European database on medical devices as a manufacturer, with 257 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class I54
Class IIb181
Class IIa22

Most frequent device types declared: 10x10 cm, 15x15 cm, 50-120 cm2, M-Pore 250x250 mm, MP 150x200 mm.

Among these devices, 235 are declared sterile, 198 implantable, 4 reusable.

Devices declared under this manufacturer

Showing 12 of 257 declared devices.

Catalogue references include MA-152-MPP0-001, MA-152-MPP0-002, MA-152-MRM0-003, MB-271-OPMM-004, MB-271-OPMM-011, MB-271-OPMM-013.

European nomenclature codes declared: P900202, P900403, M04050501, V80, M04040802, P080499.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED257
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 GTIN257
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. TRICOMED S.A. was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
1434-MDR-009/2024issued2029-07-11
1434-MDR-008/2024amended2029-07-11
1434-MDR-007/2024issued2029-07-11

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