Identity
- Trade Name
- Galileo NExT EUDAMEDGalileo NT Line Software FDA UDI
- Generic Name
- Bioelectrical signal analysis software FDA UDI
- Device Name
- MDSW Family EUDAMEDSoftware for EEG, EMG, EP and other applications based on acquiring, processing and analyzing of biological electrical signals. Identifier (8012) contains the software version. FDA UDI
- Model / Reference
- B8640053000 EUDAMEDFDA UDI
- Description
- Software for EEG, EMG, EP and other applications based on acquiring, processing and analyzing of biological electrical signals. Identifier (8012) contains the software version. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08056446900642 EUDAMEDFDA UDI
- Basic UDI-DI
- 080564469MDSW_EK EUDAMED
- FDA Product Code
- JXE FDA UDIOLV FDA UDIGWJ FDA UDIGWE FDA UDIGWF FDA UDIIKN FDA UDIGWQ FDA UDIOLT FDA UDI
- EMDN Code
- Z12109092 VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Bioelectrical signal analysis software FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1550 FDA UDI882.1400 FDA UDI882.1900 FDA UDI882.1890 FDA UDI882.1870 FDA UDI890.1375 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Galileo NExT by EB Neuro S.p.A. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 080564469MDSW_EK | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- EB Neuro S.p.A.
- EUDAMED SRN
- IT-MF-000027944
Sources (2)
- EUDAMED 2ba8f343-d070-44e4-bfc4-1ba73d166c79 61 fields · synced Jul 19, 2026
- FDA UDI bdd6ca75-8c5a-445f-adda-22b303974d93 35 fields · synced May 25, 2026