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CloNext 24 Automated Nucleic Acid Purification System
EUDAMEDClass A (EU MDR)
Ref OP01019Model CLONEXT 12 AUTOMATED NUCLEIC ACID PURIFICATION SYSTEM
by Clonit srl
Identity
- Trade Name
- CloNext 24 Automated Nucleic Acid Purification System EUDAMED
- Device Name
- OP01018 EUDAMED
- Model / Reference
- CLONEXT 12 AUTOMATED NUCLEIC ACID PURIFICATION SYSTEM EUDAMEDOP01019 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08057680910725 EUDAMED
- Basic UDI-DI
- 805768091Clonext_013D EUDAMED
- Direct Marketing DI
- 08057680910725 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 24 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 805768091Clonext_013D | Class A | Active |
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Manufacturer
- Manufacturer
- Clonit srl
- EUDAMED SRN
- IT-MF-000022196
Sources (1)
- EUDAMED 06e31d91-39d0-4bab-be6b-2d606403b4b9 61 fields · synced Jun 19, 2026