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Cuffia EEG BE PLUS LTM / BE PLUS PRO 10 Elettrodi Ag/AgCl+A1+A2 Misura 2
EUDAMEDFDA UDIClass I (EU MDR)
Ref B9602094732Ref B9602094711Ref B9602094713Ref B9602094733Ref B9800078004
Identity
- Trade Name
- Cuffia EEG BE PLUS LTM / BE PLUS PRO 10 Elettrodi Ag/AgCl+A1+A2 Misura 2 EUDAMEDCuffia EEG BE PLUS LTM / BE PLUS PRO 10 Elettrodi Cilindrici Ag/AgCl+A1+A2 Misura 1 EUDAMEDCuffia EEG BE PLUS LTM / BE PLUS PRO 10 Elettrodi Cilindrici Ag/AgCl+A1+A2 Misura 3 EUDAMEDCuffia EEG BE PLUS LTM / BE PLUS PRO 10 Elettrodi Ag/AgCl+A1+A2 Misura 3 EUDAMEDBE PLUS PRO EUDAMEDBE PLUS PRO [ADVANCED] FDA UDI
- Generic Name
- Electroencephalograph FDA UDI
- Device Name
- EEG Accessories EUDAMEDEEG Family EUDAMEDBE PLUS PRO [ADVANCED] is an active medical device aimed to collect and record physiological signals from human body. It includes amplifier and accessories. FDA UDI
- Model / Reference
- B9602094732 EUDAMEDB9602094711 EUDAMEDB9602094713 EUDAMEDB9602094733 EUDAMEDB9800078004 EUDAMEDFDA UDI
- Description
- BE PLUS PRO [ADVANCED] 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
- 08056446906514 EUDAMED08056446906361 EUDAMED08056446906385 EUDAMED08056446906521 EUDAMED08056446901342 EUDAMEDFDA UDI
- Basic UDI-DI
- 080564469AccessoriEEG_KN EUDAMED080564469EEG_BE EUDAMED
- 510(k) Number
- K242305 FDA UDI
- FDA Product Code
- GWL FDA UDIGWQ FDA UDIOLT FDA UDIOLV FDA UDI
- EMDN Code
- N01010203 EEG HEADSETS EUDAMEDZ12109099 VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Electroencephalograph FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass 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
Cuffia EEG BE PLUS LTM / BE PLUS PRO 10 Elettrodi Ag/AgCl+A1+A2 Misura 2 by EB Neuro S.p.A. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 080564469AccessoriEEG_KN | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- EB Neuro S.p.A.
- EUDAMED SRN
- IT-MF-000027944
Sources (6)
- EUDAMED 21e822bf-2306-4936-9de5-65b7eb3daa45 61 fields · synced Jul 11, 2026
- EUDAMED 9d9daad9-af84-49eb-b667-1f95d6a6b454 61 fields · synced May 18, 2026
- EUDAMED 7597e906-456b-4797-b318-1de5a6d3fa7c 61 fields · synced May 18, 2026
- EUDAMED 8ba17430-ef07-46ac-a7e3-b498914e3669 61 fields · synced May 19, 2026
- FDA UDI 32946777-ecf1-4ca7-b7a5-5e379e3eb3e9 35 fields · synced May 30, 2026
- EUDAMED 471e4416-9088-44d7-951c-7886e884c67e 61 fields · synced Jul 10, 2026