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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

Prime MDX PFP Extraction Kit 2x24… — IVDR Class A IVDR

MD Atlas
A. MENARINI Diagnostics S.r.l.

EUDAMED last updated this device on Apr 16, 2025

Prime MDX PFP Extraction Kit 2x24 rxn

8012992PMDXEKYY

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: A. MENARINI Diagnostics S.r.l.
UDI-DI code: 08012992564455
Reference / catalog number: 56445

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View device family (Basic UDI)

Manufacturer information

Organization name: A. MENARINI Diagnostics S.r.l.
SRN: IT-MF-000023427
Manufacturer status: Active

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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

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

CW265
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Italy; available across 1 country total.

Placed on the market in Italy; per-country availability dates not published.

Device identification

Trade name: Prime MDX PFP Extraction Kit 2x24 rxn
UDI-DI code: 08012992564455
Basic UDI-DI: 8012992PMDXEKYY
Reference / catalog number: 56445
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: The PRIME MDx DNA/RNA Extraction kit is presented as a prefilled plate of 24 samples (56445) and is designed, developed and produced exclusively for use on the PRIME MDx molecular diagnostic platform.
Additional information URL: https://www.menarinidiagnostics.com/en-us/
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)08012992564455

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

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

W0105900101REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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