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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

KTCH3PBTE-E — Class IIa MDD by CARDIOLINE SpA

MD Atlas
CARDIOLINE SpA

EUDAMED last updated this device on Oct 6, 2025

KTCH3PBTE-E

B-08056732651616

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: CARDIOLINE SpA
UDI-DI code: 08056732651616
Reference / catalog number: KTCH3PBTE-E

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View device family (Basic UDI)

Manufacturer information

Organization name: CARDIOLINE SpA
SRN: IT-MF-000029682
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	Jul 7, 2016	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08056732651616
Basic UDI-DI: B-08056732651616
Reference / catalog number: KTCH3PBTE-E
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC 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.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08056732651616

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Z12050302ADVANCED DIAGNOSIS 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

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Related devices

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Certificates

Certificate health across this manufacturer's portfolio.

ITH 1343191 1Issued
Quality management systemNotified body: 1936Expiry: Oct 20, 2029