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Organization name
UDI-DI code
Reference / catalog number

05904815554602 — Class IIa MDR by Sieć Badawcza…

MD Atlas
Sieć Badawcza Łukasiewicz - Krakowski Instytut Technologiczny

EUDAMED last updated this device on Jul 12, 2024

05904815554602

59048155546_ERT200ZS

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: 05904815554602
Reference / catalog number: 05904815554602

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View device family (Basic UDI)

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.
CW016
treadmil
CW017
for optional HR meassurement

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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: 05904815554602
Basic UDI-DI: 59048155546_ERT200ZS
Reference / catalog number: 05904815554602
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: The ERT-200 treadmill is designed to inflict a load while conducting: (1) exercise tests under the care of a doctor; (2) rehabilitation training under the care of a rehabilitation specialist or doctor.
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.

Z129006TREADMILLS FOR PHYSIOTHERAPY AND/OR DIAGNOSTIC USES

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