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CloNext 12 Automated Nucleic Acid Purification System

EUDAMED

Class A (EU MDR)

Ref OP01018Model CLONEXT 12 AUTOMATED NUCLEIC ACID PURIFICATION SYSTEM

by Clonit srl

Identity

Trade Name
CloNext 12 Automated Nucleic Acid Purification System EUDAMED
Device Name
OP01018 EUDAMED
Model / Reference
CLONEXT 12 AUTOMATED NUCLEIC ACID PURIFICATION SYSTEM EUDAMED
OP01018 EUDAMED

Identifiers

Primary DI / UDI-DI
08057680911333 EUDAMED
Basic UDI-DI
805768091Clonext_013D EUDAMED
Direct Marketing DI
08057680911333 EUDAMED
EMDN Code
W02079099 VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - OTHER EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Italy EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

No

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

Yes

EUDAMED

New Device

No

EUDAMED

CloNext 12 Automated Nucleic Acid Purification System by Clonit srl — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

Manufacturer
Clonit srl
EUDAMED SRN
IT-MF-000022196

Sources (1)

  • EUDAMED 477392ce-bef0-433f-b26d-b7e5c7aaaeff 61 fields · synced Jun 18, 2026