Identity
- Trade Name
- MediByte Kit EUDAMEDBRAEBON MediByte FDA UDI
- Generic Name
- Polysomnograph FDA UDI
- Device Name
- MediByte Kit EUDAMEDThe MediByte is a portable sleep data recorder used to record physiological signals during sleep while the patient is either at home or in a clinical environment. Kit contains 1 MediByte, 2 Q-RIP Effort Belts, 6 Patient Kits, 1 SpO2 Sensor, 1 Communication Cable. FDA UDI
- Model / Reference
- MP8KN EUDAMEDMP8K-Lite EUDAMEDMp8KLite FDA UDI
- Description
- The MediByte is a portable sleep data recorder used to record physiological signals during sleep while the patient is either at home or in a clinical environment. Kit contains 1 MediByte, 2 Q-RIP Effort Belts, 6 Patient Kits, 1 SpO2 Sensor, 1 Communication Cable. FDA UDI
Identifiers
- Catalog Number
- MP8KLite FDA UDI
- Primary DI / UDI-DI
- B140MP8KLITE0 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B140MBKITWM EUDAMED
- 510(k) Number
- K061764 FDA UDI
- FDA Product Code
- MNR FDA UDI
- EMDN Code
- Z12100501,Z12100580,Z12100585 EUDAMED
- GMDN Term
- Polysomnograph FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.2375 FDA UDI
- Medical Purpose
- Portable recorder for HST. The MediByte in combination with included devices used to diagnose sleep disorders, such as sleep apnea, upper airway resistance, snoring, periodic limb movements and bruxism. EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA 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
MediByte Kit by Braebon Medical Corporation — Class IIa — 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 | ++B140MBKITWM | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- BRAEBON Medical Corporation
- EUDAMED SRN
- CA-PR-000013743
Sources (2)
- EUDAMED 5f3084a0-4ca7-46ac-8477-1784020f7042 61 fields · synced Jun 1, 2026
- FDA UDI 7b2f3633-e17a-4e13-bce9-28e32a6f15a5 37 fields · synced May 30, 2026