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Organization name
UDI-DI code
Reference / catalog number

medilog DARWIN2 AAM — Class IIa MDR by SCHILLER AG

MD Atlas
SCHILLER AG

EUDAMED last updated this device on Feb 23, 2026

medilog DARWIN2 AAM

761336500000001455

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SCHILLER AG
UDI-DI code: 07613365003673
Reference / catalog number: 5.000005

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Manufacturer information

Organization name: SCHILLER AG
SRN: CH-MF-000012722
Manufacturer status: Active

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Market distribution

Primary placement in Austria; available across 2 countries total.

Country	On market since	Until
AustriaPrimary placement		Still on market
Germany		Still on market

Device identification

Trade name: medilog DARWIN2 AAM
UDI-DI code: 07613365003673
Basic UDI-DI: 761336500000001455
Reference / catalog number: 5.000005
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: medilog DARWIN2 is a data management and analysis program for electronic storage, transfer, display and processing of physiological signals and medical patient information used in combination with long-term continuous ECG or ambulatory blood pressure monitoring devices. The medilog DARWIN2 software functions include: Displaying and analyzing of physiological signals (ECG, heart rate, ECG-derived respiration, SpO2, BP measurement, BP pulse wave analysis). Calculating and displaying the statistical values of those data. Detecting and classifying heart activities (atrial, ventricular) and arrhythmias. Configuring long-term continuous ECG Holter devices and automated non-invasive sphygmomanometer blood pressure devices.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12050401CARDIOVASCULAR HOLTER ANALYSERS

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

Certificates

Certificate health across this manufacturer's portfolio.

G10 041505 0132Issued
Quality management systemNotified body: 0123Expiry: Nov 11, 2026