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Organization name
UDI-DI code
Reference / catalog number

CARDIOVIT FT-1 CRO — Class IIa MDR by SCHILLER AG

MD Atlas
SCHILLER AG

EUDAMED last updated this device on Sep 18, 2025

CARDIOVIT FT-1 CRO

761336500000002152

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SCHILLER AG
UDI-DI code: 07613365003642
Reference / catalog number: 3.900865

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Manufacturer information

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

Related devices

PB-3000 Var. 476133650000000014UOn the market PB-3000 Var. 7, sub-variant: C (main device 3.921008)76133650000000014UOn the market ARGUS LifePoint761336500000001659On the market ARGUS LifePoint 2761336500000001659On the market ARGUS PB-1000B-07613365000092On the market

Market distribution

Primary placement in Germany; available across 2 countries total.

Country	On market since	Until
GermanyPrimary placement	Oct 24, 2018	Nov 23, 2029
Austria	Jul 5, 2019	Nov 23, 2029

Device identification

Trade name: CARDIOVIT FT-1 CRO
UDI-DI code: 07613365003642
Basic UDI-DI: 761336500000002152
Reference / catalog number: 3.900865
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: —
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