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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

ECG Electrodes — Class I MDR by SORIMEX sp. z o.o.

MD Atlas
SORIMEX sp. z o.o.

EUDAMED last updated this device on Apr 23, 2024

ECG Electrodes

5903002221135D

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SORIMEX sp. z o.o.
UDI-DI code: 05908212624081
Reference / catalog number: EK-1/23 WpHG/2j-L50/RTG

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Manufacturer information

Organization name: SORIMEX sp. z o.o.
SRN: PL-MF-000020958
Manufacturer status: Active

Related devices

ECG monitoring cable5903002221085LOn the market NIBP cuff5903002221195ROn the market NIBP cuff5903002221195ROn the market =leadwires59030022211057On the market disposable ECG electrodes5903002223235SOn the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Poland; available across 1 country total.

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

Device identification

Trade name: ECG Electrodes
UDI-DI code: 05908212624081
Basic UDI-DI: 5903002221135D
Reference / catalog number: EK-1/23 WpHG/2j-L50/RTG
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: 3
Additional product description: Disposable ECG electrodes with wire, wire connector 23 x 23 mm, hydrogel, non-woven fabric, intended for newborns, recommended for X-ray, set. 3 pcs
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.

C020501ECG ELECTRODES

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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