Identity
- Trade Name
- NExT Advanced EUDAMEDNExT Station Advanced FDA UDI
- Generic Name
- Electromyograph FDA UDI
- Device Name
- EMG Family EUDAMEDEMG/EP Amplifier with accessories FDA UDI
- Model / Reference
- B9800096000 EUDAMEDFDA UDI
- Description
- EMG/EP Amplifier with accessories FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08056446901090 EUDAMEDFDA UDI
- Basic UDI-DI
- 080564469EMG_CN EUDAMED
- FDA Product Code
- GWL FDA UDIOLT FDA UDIIKN FDA UDIGWE FDA UDIGWF FDA UDIGWJ FDA UDI
- EMDN Code
- Z12100401 ELECTROMYOGRAPHS EUDAMED
- GMDN Term
- Electromyograph FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1835 FDA UDI882.1400 FDA UDI890.1375 FDA UDI882.1890 FDA UDI882.1870 FDA UDI882.1900 FDA UDI
- 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
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
NExT Advanced 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 | 080564469EMG_CN | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- EB Neuro S.p.A.
- EUDAMED SRN
- IT-MF-000027944
Sources (2)
- EUDAMED 36159f84-dfa0-46aa-a51c-4b2ad633f61a 61 fields · synced Jun 6, 2026
- FDA UDI 9b1c5d29-966b-41e8-a423-e4d00eeb08fc 34 fields · synced May 30, 2026