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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

CardioHis app — Class IIa MDR by CARDIOHIS, S.L.

MD Atlas
CARDIOHIS, S.L.

EUDAMED last updated this device on May 4, 2026

CardioHis app

843702613202C6

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: CARDIOHIS, S.L.
UDI-DI code: 08437026132019
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: CardioHis app
UDI-DI code: 08437026132019
Basic UDI-DI: 843702613202C6
Reference / catalog number: CHIS_001_B.1_Instructions for Use
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: CardioHis app is a software used in conjunction with the CardioHis device to display the ECG signals acquired with it. It also allows measurements to be made on the ECG obtained in real time by using a system of marks (calipers) to analyze various electrocardiographic variables. This feature makes measurements of the many variables (heart rate, distance between R waves, QRS duration)
Additional information URL: https://www.cardiohis.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12050392ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE

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

CH0004843702613203C8On 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.