Identity
- Trade Name
- BE PLUS PRO LIGHT FDA UDI
- Generic Name
- Electroencephalograph FDA UDI
- Device Name
- Acquisition unit FDA UDI
- Model / Reference
- B9700078001 FDA UDI
- Description
- Acquisition unit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08056446900895 FDA UDI
- 510(k) Number
- K242305 FDA UDI
- FDA Product Code
- GWL FDA UDIGWQ FDA UDI
- GMDN Term
- Electroencephalograph FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1835 FDA UDI882.1400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Electroencephalograph
Be Plus Pro Light by Eb Neuro Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electroencephalograph.
- Natus — Natus Neurology Incorporated · Class II
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- Natus — Natus Neurology Incorporated · Class II
- Sleep Profiler PSG2 — Advanced Brain Monitoring, Inc. · Class II
- Natus — Natus Neurology Incorporated · Class II
- 128-channel EEG cap (L) — Megin Oy · Class II
- Compumedics Neuvo — COMPUMEDICS LIMITED · Class II
- Zeto ONE Head Unit - Small — ZETO INC · Class II
Cleared under the same submission
K242305 also covers:
- BE PLUS LTM PULSE OXIMETER — EB NEURO SPA
- BE PLUS PRO ADVANCED — EB NEURO SPA
- BE PLUS PRO Battery Pack — EB NEURO SPA
- BE PLUS PRO FULL — EB NEURO SPA
- BE PLUS PRO STANDARD — EB NEURO SPA
- Battery Charger — EB NEURO SPA
- Flash Led Stimulator — EB NEURO SPA
- Isolation Transformer ‘GP’ 110-120 VAC 50/60 Hz — EB NEURO SPA
- Neurotravel LIGHT Base Unit — EB NEURO SPA
- USB FLASH ADAPTER CABLE L=3m — EB NEURO SPA
- USB FLASH ADAPTER CABLE L=5m — EB NEURO SPA
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Eb Neuro Spa
Sources (1)
- FDA UDI 56e01326-2c46-4a68-98ff-1b17bb090d16 35 fields · synced Jun 8, 2026