EU → North America Device Access

LANGSTEINER SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ

PL-MF-000010968 · Poland · Mników

LANGSTEINER SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ is registered in the European database on medical devices as a manufacturer, with 43 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class I42
Class IIa1

Most frequent device types declared: 8 szt, Plastry na odciski z kwasem salicylowym, Plastry na odciski z kwasem salicylowym komfort, corn plasters with salicylic acid.

Devices declared under this manufacturer

Showing 12 of 43 declared devices.

Catalogue references include 40-0001 11, 40-0001 14, 40-0001 18, 40-0001 20, 40-0001 25, 40-0001 27.

European nomenclature codes declared: M0412, M0410.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED43
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 GTIN43
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. LANGSTEINER SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
TNP/MDR/0058/3906/2026issued2029-06-23
TNP/MDR/0057/3906/2026issued2029-06-23

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