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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

Holter ECG cable — Class I MDR by SORIMEX sp. z o.o.

MD Atlas
SORIMEX sp. z o.o.

EUDAMED last updated this device on Mar 14, 2025

Holter ECG cable

5903002221095N

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SORIMEX sp. z o.o.
UDI-DI code: 05903002210932
Reference / catalog number: KH-2/0-Ha/0-0/L-18/32-905

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View device family (Basic UDI)

Manufacturer information

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

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Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW018
https://www.sorimex.eu/13/instructions-for-use-and-storage

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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: Holter ECG cable
UDI-DI code: 05903002210932
Basic UDI-DI: 5903002221095N
Reference / catalog number: KH-2/0-Ha/0-0/L-18/32-905
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: ECG cable for Holter, non-detachable, KH-2/0 connector, without plug, Ha/0 latch, length 18/32 cm, pack of 1.
Additional information URL: https://www.sorimex.pl/
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)05903002210932

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

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

Z12050380ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES
Z12050480HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - HARDWARE ACCESSORIES
C020599CARDIAC DIAGNOSTIC DEVICES - OTHER

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

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.