EU → North America Device Access

ChM spółka z ograniczoną odpowiedzialnością

PL-MF-000002121 · Poland · JUCHNOWIEC KOŚCIELNY

ChM spółka z ograniczoną odpowiedzialnością is registered in the European database on medical devices as a manufacturer, with 18 608 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa11 221
Class IIb7 387

Most frequent device types declared: CERVICAL PLATES, CRANIOFACIAL PLATES, Forceps, Gouge, Holder.

Among these devices, 3 169 are declared sterile, 7 387 implantable, 7 601 reusable, 4 active.

Catalogue references include 3.3473.015S, 3.3729.006, 3.3810.010S, 3.3813.204S, 3.4492.006, 3.4634.006.

European nomenclature codes declared: P09120599, L091099, V9099, L0916, L091001, P09120202.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED18 608
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 GTIN18 608
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. ChM spółka z ograniczoną odpowiedzialnością was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
IZ 1023642-2issued2031-01-18
IZ 1023642-1issued2030-12-30
HZ 1023642-1supplemented2030-04-29

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