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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

9463S — IVDR Class C IVDR by Eurospital Spa

MD Atlas
Eurospital Spa

EUDAMED last updated this device on Feb 27, 2026

9463S

802816920CW01060402055E

On the marketIVDR Class C

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Eurospital Spa
UDI-DI code: 08028169208916
Reference / catalog number: 9463S

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Manufacturer information

Organization name: Eurospital Spa
SRN: IT-MF-000028468
Manufacturer status: Active

Critical warnings

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

CW010
The Eu-Gen MTHFR Dual-Type kit must not be used for purposes other than those stated in the "Intended use". Strictly follow the described procedure.
CW007
If the outer packaging is damaged, make sure that all components listed in the section 'Materials supplied' are present and undamaged. If liquid leaks from the bottles, the kit must not be used.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	Oct 11, 2024	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08028169208916
Basic UDI-DI: 802816920CW01060402055E
Reference / catalog number: 9463S
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Qualitative kit in Multiplex Real Time PCR for the determination of the allelic variants MTHFR A1298C and MTHFR C677T related to the increase risk of cardiovascular disorders. For professional use only
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

EMDN nomenclature code(s)

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

W0106010499POLYMORPHISM TESTS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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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.