05904815540018

Organization name

Sieć Badawcza Łukasiewicz - Krakowski Instytut Technologiczny

SRN

PL-MF-000001669

Manufacturer status

Active

4 warnings recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.
• CW017

  EUDAMED did not publish a description for this code.
• CW011

  EUDAMED did not publish a description for this code.
• CW014

  for optional temperature meassurement

Primary placement in Poland; available across 1 country total.

Trade name

not provided

UDI-DI code

05904815540018

Basic UDI-DI

59048155400_PELECARD4E

Reference / catalog number

05904815540018

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

Product System PELETON-CARDIV is a computer-based system, equipped with appropriate software and ECG signal acquisition modules. Depending on configuration, it is capable of: - supporting resting and stress ECG tests, - conducting group rehabilitation exercises, which are part of the second stage of cardiac rehabilitation, - performing cardiac supervision of other group trainings, e.g. in changing environmental conditions.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z12050701COMPLETE CARDIOGRAPHY SYSTEMS

Certificate health across this manufacturer's portfolio.