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CloNext TB DNA Extraction Kit
EUDAMEDClass A (EU MDR)
Ref OP02008-48
by Clonit srl
Identity
- Trade Name
- CloNext TB DNA Extraction Kit EUDAMED
- Device Name
- CloNext TB DNA Extraction Kit EUDAMED
- Model / Reference
- OP02008-48 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08057680911128 EUDAMED
- Basic UDI-DI
- 805768091CNextTBDNA_013Q 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
Category: Nucleic acid extraction/isolation kit IVD
CloNext TB DNA Extraction Kit by Clonit srl — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Nucleic acid extraction/isolation kit IVD.
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- MagPure RNA Kit — Chaozhou Hybribio Biochemistry Ltd. · Class A
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 | 805768091CNextTBDNA_013Q | Class A | Active |
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Manufacturer
- Manufacturer
- Clonit srl
- EUDAMED SRN
- IT-MF-000022196
Sources (1)
- EUDAMED b50623b2-d21d-4302-815d-3505de929cf4 61 fields · synced Aug 4, 2026