CARNAMEDICA SP Z O O

FDA Device Registration & Listing · Warszawa Mazowieckie, PL · Registration 3017223202

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3017223202
FEI Number
3017223202
Entity Name
CARNAMEDICA SP Z O O
City/State/Country
Warszawa Mazowieckie, PL
Establishment Address
ul. Olszynki Grochowskiej, 21 lok U6, Warszawa Mazowieckie 04-281, PL
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Carnamedica Sp z o o (Owner Number: 10087808)
Owner / Operator Contact Address
ul. Olszynki Grochowskiej, 21 lok U6, Warszawa, PL-14 04-281, PL
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K240650
PMA Number
N/A

All Registered Proprietary Names

Cannula for Organ Perfusion XPort Lung Preservation Solution LungProtect®

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KDN System, Perfusion, Kidney Gastroenterology, Urology Class 2 876.5880 2023-04-12
MSB System And Accessories, Isolated Heart, Transport And Preservation Gastroenterology, Urology Class 2 876.5880 2023-04-12
KDN System, Perfusion, Kidney Gastroenterology, Urology Class 2 876.5880 2025-06-24
KDN System, Perfusion, Kidney Gastroenterology, Urology Class 2 876.5880 2025-06-24

Official Correspondent

Pawel Szczudlo

US Agent Details

Stephan Toupin Business: Dawa Medical LLC Email: stoupin@dawamedical.com Phone: (305) 5999373

Related Public Records

Same Entity

Carnamedica Sp z o o
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K013575 Organ Recovery Systems, Inc. KPS-I, THE KIDNEY PERFUSION SOLUTION 2002-01-25

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017223202. Last updated year: 2026. Please use registration number 3017223202 when referencing this establishment in official correspondence.
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