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SpiNXT Cell free DNA Extraction Kit
EUDAMEDClass A (EU MDR)
Ref G2M810013-50TModel G2M810013Ref G2M810013-250T
Identity
- Trade Name
- SpiNXT Cell free DNA Extraction Kit EUDAMED
- Device Name
- SpiNXT Cell free DNA Extraction Kit EUDAMED
- Model / Reference
- G2M810013 EUDAMEDG2M810013-50T EUDAMEDG2M810013-250T EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906178200643 EUDAMED08906178200650 EUDAMED
- Basic UDI-DI
- 890617820G2M810013GB EUDAMED
- Direct Marketing DI
- 08906178200643 EUDAMED08906178200650 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
- 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
New Device
No
EUDAMED
Category: Nucleic acid extraction/isolation kit IVD
SpiNXT Cell free DNA Extraction Kit by Genes 2Me Private Limited — 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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- 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 | 890617820G2M810013GB | Class A | 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 (2)
- EUDAMED 90083086-bd12-45d9-a78a-cdf46cd1da83 61 fields · synced Jul 29, 2026
- EUDAMED dd7bc3cd-3552-43e4-b602-0c613d1cb64e 61 fields · synced May 18, 2026