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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

CHES.Flag — Class IIa MDR by ESD - Evaluation…

MD Atlas
ESD - Evaluation Software Development GmbH

EUDAMED last updated this device on Dec 18, 2025

CHES.Flag

912013060CHES.FlagN7

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ESD - Evaluation Software Development GmbH
UDI-DI code: 91201306000394
Reference / catalog number: CHES.Flag

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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	Dec 18, 2025	Jul 15, 2030
Germany	Dec 18, 2025	Jul 15, 2030

Device identification

Trade name: not provided
UDI-DI code: 91201306000394
Basic UDI-DI: 912013060CHES.FlagN7
Reference / catalog number: CHES.Flag
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 purpose of CHES.Flag is to support physicians in the administration, calculation and interpretation of clinically validated questionnaires as part of patient care. Integrated into CHES (accessory to CHES.Flag), CHES.Flag calculates questionnaire scores for each clinically validated questionnaire based on defined and established formulas and places them in a clinical reference framework. Using CHES.Flag, physicians can be supported in the assessment of clinically valid questionnaires by automatic calculation, eliminating the need for individual, unproven calculation solutions. In addition, the physician can be assisted in the interpretation of the questionnaire score by embedding the score in the context of established clinical reference values, which can support the clinician in diagnostic and therapeutic decision making.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12040192GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - 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

912013060CHES27912013060CHES27On 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.