Identity
- Device Name
- NX Genomic DNA Kit A EUDAMED
- Model / Reference
- NGD961 EUDAMEDCVD231 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800174502377 EUDAMED
- Basic UDI-DI
- 88001745-48N-R-NY EUDAMED
- Direct Marketing DI
- 08800174502377 EUDAMED
- EMDN Code
- W0105040599 VIROLOGY - NA REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain 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
NX Genomic DNA Kit A by Genolution. Inc. — 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 | 88001745-48N-R-NY | Class A | Active |
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Manufacturer
- Manufacturer
- Genolution Inc.
- EUDAMED SRN
- KR-MF-000010391
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED e87803cc-54d4-4ed1-8e61-b759d3815618 61 fields · synced Jun 19, 2026