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LeoNext CfDNA Library Prep Kit
EUDAMEDClass IVD General (EU MDR)
Ref NGS3105-01 NGS3105-02 NGS3105-03Model NGS3105
Identity
- Trade Name
- LeoNext CfDNA Library Prep Kit EUDAMED
- Device Name
- LeoNext CfDNA Library Prep Kit EUDAMED
- Model / Reference
- NGS3105 EUDAMEDNGS3105-01 NGS3105-02 NGS3105-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-NGS3105WU EUDAMED
- Basic UDI-DI
- B-NGS3105WU EUDAMED
- EMDN Code
- W0106010399 CHROMOSOMAL DISORDERS TESTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Belgium 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
LeoNext CfDNA Library Prep Kit by Genes 2Me Private Limited — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-NGS3105WU | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Genes 2Me Private Limited
- EUDAMED SRN
- IN-MF-000035953
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED a26e1cd4-9b26-4e4a-a33d-f7a68fba1fbd 61 fields · synced Jul 30, 2026