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F.R.K. "INTRA-CORDIS" Spółka z ograniczoną odpowiedzialnością

Poland·PL-MF-000019081

Last updated September 17, 2026

What F.R.K. "INTRA-CORDIS" Spółka z ograniczoną odpowiedzialnością makes

F.R.K. "INTRA-CORDIS" Spółka z ograniczoną odpowiedzialnością manufactures external ventricular circulatory assist systems, including the Kaniula pozaustrojowej pompy wspomagania serca POLVAD–MEV and the Pozaustrojowa pompa wspomagania serca POLVAD–MEV.

The company's portfolio includes Class III and Class IIb devices, which are listed in the eudamed registry. F.R.K. "INTRA-CORDIS" is based in Poland.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What type of medical devices does F.R.K. "INTRA-CORDIS" manufacture?

The company produces external ventricular circulatory assist systems, which are devices designed to support heart function outside the body. This is evident from the device categories listed and the specific examples such as the POLVAD–MEV pumps, confirming the focus on ventricular assist technology.

Where is F.R.K. "INTRA-CORDIS" located?

F.R.K. "INTRA-CORDIS" is based in Poland, as indicated by the COUNTRY field in the provided data. The company’s legal name includes "Spółka z ograniczoną odpowiedzialnością," a Polish form of limited liability company, confirming its Polish location.

Which regulatory registry lists the devices from F.R.K. "INTRA-CORDIS"?

The devices are listed in the European Union database for medical devices, known as eudamed. The LISTED IN field explicitly mentions eudamed, showing that the company's products are recorded in this EU-wide registry.

How are the devices from F.R.K. "INTRA-CORDIS" classified under EU regulations?

The company's portfolio includes devices classified as Class III and Class IIb. These classifications are stated in the DEVICE CLASSES field, indicating that some devices are high‑risk (Class III) while others are medium‑risk (Class IIb) according to EU medical device rules.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
Poland
Address
48, H. Sienkiewicza, Zabrze, Poland
LinkedIn
—
Facebook
—
Phone
—
PRRC Contact
Łukasz Mucha
EUDAMED SRN
PL-MF-000019081
FDA FEI Number
—
DUNS Number
—

Catalogue (2)

DeviceModel / ReferenceRegistriesClassStatus
Kaniula pozaustrojowej pompy wspomagania serca POLVAD–MEV 05903981371624
EUDAMED
Class IIIActive
Pozaustrojowa pompa wspomagania serca POLVAD–MEV 05903981371617
EUDAMED
Class IIbActive

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