Data / Medical devices / Poland / Carnamedica SP Z O O

Carnamedica SP Z O O: FDA-registered device maker in Warszawa Mazowieckie, Poland, 1 510(k) clearance

Name: Carnamedica SP Z O O FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Carnamedica SP Z O O is registered with the FDA (registration 3017223202) in Warszawa Mazowieckie, Poland. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 26, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3017223202
Address: ul. Olszynki Grochowskiej 21 lok U6, Warszawa Mazowieckie, Poland, 04-281
Owner or operator: Carnamedica Sp z o o (10087808)
Roles: Contract manufacturer, Manufacturer
First device listed: April 12, 2023
Registered through: 2026
Brand names listed: Cannula for Organ Perfusion, LungProtect®, XPort Lung Preservation Solution

Devices it lists

Device	Product code	Class	Role	Source
System And Accessories, Isolated Heart, Transport And Preservation	MSB	2	Contract manufacturer	accessdata.fda.gov
System, Perfusion, Kidney	KDN	2	Contract manufacturer, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 26, 2024	K240650	LungProtect	KDN	Substantially Equivalent	Traferox Technologies, Inc.	accessdata.fda.gov

Compare with other makers

Updated November 26, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.