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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

VDISYS001 — Class IIa MDR by VDI Technologies s.r.o.

MD Atlas
VDI Technologies s.r.o.

EUDAMED last updated this device on Jun 10, 2025

VDISYS001

859421406UHFECGLP

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: VDI Technologies s.r.o.
UDI-DI code: 08594214060018
Reference / catalog number: VDISYS001

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Manufacturer information

Organization name: VDI Technologies s.r.o.
SRN: CZ-MF-000029098
Manufacturer status: Active

Critical warnings

2 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.

Market distribution

Primary placement in Czechia; available across 1 country total.

Country	On market since	Until
CzechiaPrimary placement	Jun 17, 2025	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08594214060018
Basic UDI-DI: 859421406UHFECGLP
Reference / catalog number: VDISYS001
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: VDI UHF-ECG is intended for the detection, normalization, and digitization of electrocardiographic signals from medical patients using ultra-high frequencies (UHF) (from 150 Hz to 1 kHz). The primary function of the device is to receive and analyze UHF-ECG signals to a connected computer.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12050302ADVANCED DIAGNOSIS ELECTROCARDIOGRAPHS

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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

DB 14-lead ECG leadwires disposable859421406CLWPUOn the market DB 14-lead ECG trunk cable859421406CLWPUOn the market N/A859421406CLWPUOn the market

Certificates

Certificate health across this manufacturer's portfolio.

8801-MD-00001-25Issued
Quality management systemNotified body: 1383Expiry: May 6, 2030