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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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OP01018 — 2 UDI-DI variants, IVDR (Clonit srl)

MD Atlas
Clonit srl

Data from EUDAMED, last updated May 31, 2026

OP01018

805768091Clonext_013D

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: Clonit srl

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Device characteristics

Professional testing

Identity & classification

Basic UDI-DI: 805768091Clonext_013D
Device name: OP01018
Device model: CLONEXT 12 AUTOMATED NUCLEIC ACID PURIFICATION SYSTEM
Issuing agency: GS1
Legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk class: IVDR Class A
Version date: Feb 3, 2026

Manufacturer & authorised representative

Manufacturer

Name: Clonit srl
SRN: IT-MF-000022196
Country: Italy
Email: info@clonit.it
Phone: +39 0256814413

Variants by status

UDI-DI variants

2 UDI-DI variants

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Applied filters

basicUdiUlid01KGHTT4XDSBFM0HSNKPKGPVZS

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

CloNext 12 Automated Nucleic Acid Purification System08057680911333
CloNext 24 Automated Nucleic Acid Purification System08057680910725