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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

TarCET Kit - Congenital Heart… — IVDR Class A IVDR

MD Atlas
MEDICOVER GENETICS LIMITED

EUDAMED last updated this device on May 15, 2026

TarCET Kit - Congenital Heart Defects Panel

52980048MULTITN

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: MEDICOVER GENETICS LIMITED
UDI-DI code: 05298004820310
Reference / catalog number: ET206-00- 2016

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View device family (Basic UDI)

Manufacturer information

Organization name: MEDICOVER GENETICS LIMITED
SRN: CY-MF-000009381
Manufacturer status: Active

Related devices

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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.

Critical warnings

28 warnings recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.
CW032
EUDAMED did not publish a description for this code.
CW162
EUDAMED did not publish a description for this code.
CW163
EUDAMED did not publish a description for this code.
CW167
EUDAMED did not publish a description for this code.
CW168
EUDAMED did not publish a description for this code.
CW043
EUDAMED did not publish a description for this code.
CW082
EUDAMED did not publish a description for this code.
CW085
EUDAMED did not publish a description for this code.
CW090
EUDAMED did not publish a description for this code.
CW106
EUDAMED did not publish a description for this code.
CW148
EUDAMED did not publish a description for this code.
CW149
EUDAMED did not publish a description for this code.
CW159
EUDAMED did not publish a description for this code.
CW166
EUDAMED did not publish a description for this code.
CW193
EUDAMED did not publish a description for this code.
CW194
EUDAMED did not publish a description for this code.
CW414
EUDAMED did not publish a description for this code.
CW450
EUDAMED did not publish a description for this code.
CW401
In all cases of doubt, or when symptoms persist, seek medical advice. Immediate medical attention is not required.
CW397
EUDAMED did not publish a description for this code.
CW416
EUDAMED did not publish a description for this code.
CW091
EUDAMED did not publish a description for this code.
CW303
EUDAMED did not publish a description for this code.
CW117
EUDAMED did not publish a description for this code.
CW304
EUDAMED did not publish a description for this code.
CW999
P501 - Dispose of contents/container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.
CW351
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Cyprus; available across 1 country total.

Country	On market since	Until
CyprusPrimary placement		Still on market

Device identification

Trade name: TarCET Kit - Congenital Heart Defects Panel
UDI-DI code: 05298004820310
Basic UDI-DI: 52980048MULTITN
Reference / catalog number: ET206-00- 2016
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Refer to IFU
Additional information URL: https://medicover-genetics.com/partner-with-us/tarcet-kits/tarcet-kit-panels/
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

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

W01060299TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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