EU → North America Device Access

Aesculap Chifa Sp. z o.o.

PL-MF-000002120 · Poland · Nowy Tomyśl

Aesculap Chifa Sp. z o.o. is registered in the European database on medical devices as a manufacturer, with 21 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa21

Among these devices, 21 are declared reusable.

Devices declared under this manufacturer

Showing 12 of 21 declared devices.

Catalogue references include IM-043-125-HPMS, IM-043-140-PMK, IM-543-002-PMK, IM-839-002-ZMK, KN-083-125-HZMK, KO-001-002-PHMK.

European nomenclature codes declared: L150702.

United States market access

FDA establishment registerRegistered with FDA
Matched entryAESCULAP CHIFA SP. Z O.O. (PL) · FDA 9680260
Devices in EUDAMED21
Country of registrationPoland

Device-level evidence

Devices with a numeric GTIN21
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: United States only. Aesculap Chifa Sp. z o.o. is registered in the United States but was not found in the Canadian register.

Notified body certificates

CertificateStatusExpiry
G11 038951 0012issued2026-11-08

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