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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

CH0004 — Class I MDR by CARDIOHIS, S.L.

MD Atlas
CARDIOHIS, S.L.

EUDAMED last updated this device on May 11, 2026

CH0004

843702613203C8

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: CARDIOHIS, S.L.
UDI-DI code: 08437026132026
Reference / catalog number: CHIS_001_B.1_Instructions for Use

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Manufacturer information

Organization name: CARDIOHIS, S.L.
SRN: ES-MF-000046210
Manufacturer status: Active

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	Jun 25, 2025	Still on market

Device identification

Trade name: CH0004
UDI-DI code: 08437026132026
Basic UDI-DI: 843702613203C8
Reference / catalog number: CHIS_001_B.1_Instructions for Use
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: CardioHis ECG cables are limited by the indications for use of the connected CardioHis device and are intended for use only by healthcare professionals. The CardioHis ECG cables are for multiple patient use, and it is indicated for monitoring cardiac signals in adult patients.
Additional information URL: https://www.cardiohis.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

CardioHis app843702613202C6On the market CHIS_001_B.1_Instructions for Use8437026132001ZFOn 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.