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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

912013060CHES27 — Class IIa MDR by ESD - Evaluation…

MD Atlas
ESD - Evaluation Software Development GmbH

EUDAMED last updated this device on Jan 12, 2026

912013060CHES27

912013060CHES27

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ESD - Evaluation Software Development GmbH
UDI-DI code: 91201306000530
Reference / catalog number: 912013060CHES27

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Manufacturer information

Organization name: ESD - Evaluation Software Development GmbH
SRN: AT-MF-000042513
Manufacturer status: Active

Market distribution

Primary placement in Austria; available across 2 countries total.

Country	On market since	Until
AustriaPrimary placement	Jan 14, 2026	Still on market
Germany	Jan 14, 2026	Still on market

Device identification

Trade name: not provided
UDI-DI code: 91201306000530
Basic UDI-DI: 912013060CHES27
Reference / catalog number: 912013060CHES27
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: The Computer-based Health Evaluation System (CHES) is a web-based platform for efficiently supporting patient-centred care processes in medical facilities (both outpatient and inpatient). CHES is an accessory to CHES.Flag[1]. To this end, CHES offers electronic data collection (including ePROs and electronic case report forms), storage and data analysis based on a modular architecture. CHES is therefore classified as a device class IIa. Standalone use of the accessory CHES is possible; however, it does not constitute an independent medical application within the meaning of the MDR. 1CHES.Flag is a software module, used within the Computer-based Health Evaluation System (CHES). CHES.Flag offers a sophisticated system to facilitate the interpretation of patient-reported outcomes (PROs), collected in CHES, in order to support decisions for diagnostic or therapeutic purposes. As a medical device, it therefore falls under MDR Class IIa. The selection of clinically validated questionnaires is configured by the manufacturer in consultation with the customer to meet its specific needs.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12040182GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES

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

CHES.Flag912013060CHES.FlagN7On 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.