Identity
- Trade Name
- ELECTRODE BOX SE EUDAMEDBRAEBON Electrode Box SE FDA UDI
- Generic Name
- Multiple physiological signal amplifier FDA UDI
- Device Name
- Electrode Box EUDAMEDThe Electrode Box SE, which plugs into the AUX port on the MediByte®, attaches electrodes to the MediByte. FDA UDI
- Model / Reference
- 8612 EUDAMEDFDA UDI
- Description
- The Electrode Box SE, which plugs into the AUX port on the MediByte®, attaches electrodes to the MediByte. FDA UDI
Identifiers
- Catalog Number
- 8612 FDA UDI
- Primary DI / UDI-DI
- B14086120 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B140ElectrodeZ3 EUDAMED
- Direct Marketing DI
- B14086120 EUDAMED
- 510(k) Number
- K061764 FDA UDI
- FDA Product Code
- MNR FDA UDI
- EMDN Code
- Z12100580 POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Multiple physiological signal amplifier FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.2375 FDA UDI
- Market of Registration
- Germany 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
Electrode Box Se by Braebon Medical Corporation — Class I — 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 | ++B140ElectrodeZ3 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- BRAEBON Medical Corporation
- EUDAMED SRN
- CA-MF-000002190
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (2)
- EUDAMED 6fe7672f-9a62-4516-b512-d00282f48214 61 fields · synced Oct 6, 2026
- FDA UDI 8c1e3b63-1905-4ce4-9f18-1e2aee3b39eb 37 fields · synced May 30, 2026