Identity
- Trade Name
- BE PLUS PRO EUDAMEDBE PLUS PRO [FULL] FDA UDI
- Generic Name
- Electroencephalograph FDA UDI
- Device Name
- EEG Family EUDAMEDBE PLUS PRO [FULL] is an active medical device aimed to collect and record physiological signals from human body. It includes amplifier and accessories. FDA UDI
- Model / Reference
- B9800078003 EUDAMEDFDA UDI
- Description
- BE PLUS PRO [FULL] is an active medical device aimed to collect and record physiological signals from human body. It includes amplifier and accessories. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08056446901335 EUDAMEDFDA UDI
- Basic UDI-DI
- 080564469EEG_BE EUDAMED
- 510(k) Number
- K242305 FDA UDI
- FDA Product Code
- GWL FDA UDIGWQ FDA UDIOLT FDA UDIOLV FDA UDI
- EMDN Code
- Z12109099 VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Electroencephalograph FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1835 FDA UDI882.1400 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
Be Plus Pro 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 | 080564469EEG_BE | 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 7995fd5f-6406-40b2-af51-2aa81cb91edf 61 fields · synced May 30, 2026
- FDA UDI 35f0b30d-7010-48e5-b73e-3db51d27ee36 35 fields · synced May 30, 2026