Identity
- Trade Name
- NAxtra® EUDAMED
- Device Name
- NAxtra® nucleic acid extraction kit EUDAMED
- Model / Reference
- LSNX0200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07090060540076 EUDAMED
- Basic UDI-DI
- 709006054LSNXC5 EUDAMED
- Direct Marketing DI
- 07090060540076 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
- Norway 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
NAxtra® by Lybe Scientific AS — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Nucleic acid extraction/isolation kit IVD.
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- Nucleic Acid Extraction Kit — Shandong Bohong Gene Technology Co., Ltd. · Class A
- HPLC column — Immundiagnostik AG · Class A
- VIRCLIA® EXTRACTION SOLUTION — Vircell, S.L · Class A
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- Nucleic Acid Extraction Kit — Bioteke Corporation (Wuxi) Co., Ltd. · Class A
- 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 | 709006054LSNXC5 | Class A | Active |
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Manufacturer
- Manufacturer
- Lybe Scientific AS
- EUDAMED SRN
- NO-MF-000023842
Sources (1)
- EUDAMED bc0a20d3-9c2f-4024-b3e0-097e5ba6fc64 61 fields · synced Jun 18, 2026