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Organization name
UDI-DI code
Reference / catalog number

CARDIOVIT FT-2 — Class IIa MDR by SCHILLER AG

MD Atlas
SCHILLER AG

EUDAMED last updated this device on Sep 18, 2025

CARDIOVIT FT-2

76133650000000175B

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SCHILLER AG
UDI-DI code: 07613365003536
Reference / catalog number: 3.900880

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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: CARDIOVIT FT-2
UDI-DI code: 07613365003536
Basic UDI-DI: 76133650000000175B
Reference / catalog number: 3.900880
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 CARDIOVIT FT-2 is a electrocardiograph device intended to be used by or under the direct supervision of a licensed physician in healthcare facilities to acquire ECG signals from body surface electrodes, record, analyse, display and print ECGs to support diagnosis in adult and paediatric patients at rest. The spirometry option is intended to be used by or under the direct supervision of a licensed physician in healthcare facilities to record, analyze, display and print measurements and waveforms of pulmonary function tests to support diagnosis in adult and pediatric patients.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12050301GENERAL PURPOSE ELECTROCARDIOGRAPHS

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