Identity
- Trade Name
- Nextractor NX-48N EUDAMEDFDA UDI
- Generic Name
- Nucleic acid sample preparation instrument IVD FDA UDI
- Device Name
- Nextractor EUDAMED
- Model / Reference
- Nextractor EUDAMEDNX-48N EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800174502285 EUDAMEDFDA UDI
- Basic UDI-DI
- 88001745-I-RN EUDAMED
- Direct Marketing DI
- 08800174502285 EUDAMED
- FDA Product Code
- JJH FDA UDI
- EMDN Code
- W0299 IVD INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Nucleic acid sample preparation instrument IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2310 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Nextractor NX-48N by Genolution. Inc. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 88001745-I-RN | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Genolution Inc.
- EUDAMED SRN
- KR-MF-000010391
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED 76ce130d-d6cb-4414-b0de-587dc29c2c5c 61 fields · synced Jul 14, 2026
- FDA UDI c19c5134-7d8c-470b-8767-d3ee5248a936 32 fields · synced May 30, 2026