Identity
- Trade Name
- Nextractor NX-48S EUDAMED
- Device Name
- Nextractor EUDAMED
- Model / Reference
- Nextractor EUDAMEDNX-48S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800174502278 EUDAMED
- Basic UDI-DI
- 88001745-I-RN EUDAMED
- Direct Marketing DI
- 08800174502278 EUDAMED
- EMDN Code
- W0299 IVD INSTRUMENTS - 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Nextractor NX-48S 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-I-RN | 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 288b4a7b-68f2-45d1-a4d8-947f946ba67a 61 fields · synced Jul 15, 2026