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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 diagnostic cable — Class I MDR by SORIMEX sp. z o.o.

MD Atlas
SORIMEX sp. z o.o.

EUDAMED last updated this device on Aug 12, 2024

ECG diagnostic cable

5903002221075J

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SORIMEX sp. z o.o.
UDI-DI code: 05908212625163
Reference / catalog number: KT-10/i-H/0e-51e/L-70/110/200

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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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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

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

CW018
On the manufacturer's website [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: ECG diagnostic cable
UDI-DI code: 05908212625163
Basic UDI-DI: 5903002221075J
Reference / catalog number: KT-10/i-H/0e-51e/L-70/110/200
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: Non-detachable diagnostic ECG cable, KT-10/i connector, 51e plug, H/0e latch, length 70/110/200 cm, IEC color, pack. 1 pc.
Additional information URL: https://www.sorimex.pl/143/instrukcje
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.

Z12050380ELECTROCARDIOGRAPHS - 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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