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CloNext HPV DNA Extraction Kit for Swab Sample
EUDAMEDClass A (EU MDR)
Ref OP02007-48
by Clonit srl
Identity
- Trade Name
- CloNext HPV DNA Extraction Kit for Swab Sample EUDAMED
- Device Name
- CloNext HPV DNA Extraction Kit for Swab Sample EUDAMED
- Model / Reference
- OP02007-48 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08057680911111 EUDAMED
- Basic UDI-DI
- 805768091CNextHPVDNA_01ZC EUDAMED
- EMDN Code
- W0105900101 REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS 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
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
CloNext HPV DNA Extraction Kit for Swab Sample 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 | 805768091CNextHPVDNA_01ZC | Class A | Active |
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Manufacturer
- Manufacturer
- Clonit srl
- EUDAMED SRN
- IT-MF-000022196
Sources (1)
- EUDAMED 82af1d9c-f131-49df-9787-151aaf6eb3d3 61 fields · synced Jul 16, 2026