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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

05904815540032 — Class IIa MDR by Sieć Badawcza…

MD Atlas
Sieć Badawcza Łukasiewicz - Krakowski Instytut Technologiczny

EUDAMED last updated this device on Jun 22, 2023

05904815540032

59048155400_PELECARD4E

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Sieć Badawcza Łukasiewicz - Krakowski Instytut Technologiczny
UDI-DI code: 05904815540032
Reference / catalog number: 05904815540032

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Manufacturer information

Organization name: Sieć Badawcza Łukasiewicz - Krakowski Instytut Technologiczny
SRN: PL-MF-000001669
Manufacturer status: Active

Critical warnings

3 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.

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Market distribution

Primary placement in Poland; available across 1 country total.

Country	On market since	Until
PolandPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 05904815540032
Basic UDI-DI: 59048155400_PELECARD4E
Reference / catalog number: 05904815540032
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Product System PELETON-CARDIV, configuration CARDIV is a computer-based system, equipped with appropriate software and ECG signal acquisition modules. It is capable of: - supporting resting and stress ECG tests.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

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

Z12050701COMPLETE CARDIOGRAPHY SYSTEMS

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

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Certificates

Certificate health across this manufacturer's portfolio.

TNP/MDR/0045/555/2025Amended
Quality management systemNotified body: 2274Expiry: Dec 12, 2028