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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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PRIME MDx DNA/RNA Extraction kit 2 x48… — 2 UDI-DI variants, IVDR

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

Data from EUDAMED, last updated May 30, 2026

PRIME MDx DNA/RNA Extraction kit 2 x48 rxn

8012992PMDXEKYY

2 UDI-DI variants

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]IVDR Class A

Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Manufacturer: A. MENARINI Diagnostics S.r.l.

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Device characteristics

ReagentProfessional testing

Identity & classification

Basic UDI-DI: 8012992PMDXEKYY
Device name: PRIME MDx DNA/RNA Extraction kit 2 x48 rxn
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Version date: Feb 6, 2024

Manufacturer & authorised representative

Manufacturer

Name: A. MENARINI Diagnostics S.r.l.
SRN: IT-MF-000023427
Country: Italy
Email: lpolonia@menarini.it
Phone: +393498538842

Variants by status

UDI-DI variants

2 UDI-DI variants

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Applied filters

basicUdiUlid01HNZ1PZEH5NRHJQXZ7EAF5Z23

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

PRIME MDx DNA/RNA Extraction kit 2 x48 rxn08012992564462
Prime MDX PFP Extraction Kit 2x24 rxn08012992564455