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 IIa | 11 221 |
|---|---|
| Class IIb | 7 387 |
Most frequent device types declared: CRANIOFACIAL PLATES, FEMORAL BONE IMPLANTS, ROTARY SURGICAL INSTRUMENTS, NAILS FOR KNEE JOINT ARTHRODESIS, Retractor.
Among these devices, 3 169 are declared sterile, 7 387 implantable, 7 601 reusable, 4 active.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 18 608 |
| Country of registration | Poland |
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
IZ 1023642-2 | issued | 2031-01-18 |
IZ 1023642-1 | issued | 2030-12-30 |
HZ 1023642-1 | supplemented | 2030-04-29 |