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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

DB 14-lead ECG leadwires disposable — Class I MDR

MD Atlas
VDI Technologies s.r.o.

EUDAMED last updated this device on Jan 8, 2026

DB 14-lead ECG leadwires disposable

859421406CLWPU

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: VDI Technologies s.r.o.
UDI-DI code: 08594214060049
Reference / catalog number: N/A

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Manufacturer information

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

Market distribution

Primary placement in Czechia; available across 1 country total.

Placed on the market in Czechia; per-country availability dates not published.

Device identification

Trade name: DB 14-lead ECG leadwires disposable
UDI-DI code: 08594214060049
Basic UDI-DI: 859421406CLWPU
Reference / catalog number: N/A
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12050380ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES

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 trunk cable859421406CLWPUOn the market N/A859421406CLWPUOn the market VDISYS001859421406UHFECGLPOn the market

Certificates

Certificate health across this manufacturer's portfolio.

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