Identity
- Trade Name
- MediByte Electrode Prep Kit EUDAMED
- Device Name
- MediByte Patient Kit EUDAMED
- Model / Reference
- 8110 EUDAMED8128 EUDAMED
Identifiers
- Primary DI / UDI-DI
- B1408128xA0 EUDAMED
- Basic UDI-DI
- ++B140PatientKit6H EUDAMED
- EMDN Code
- Z12100585 POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Medical Purpose
- Consumables to be used with the BRAEBON MediByte for HST. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
MediByte Electrode Prep Kit by Braebon Medical Corporation — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++B140PatientKit6H | Class I | Active |
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Manufacturer
- Manufacturer
- BRAEBON Medical Corporation
- EUDAMED SRN
- CA-PR-000013743
Sources (1)
- EUDAMED f9cd9fd2-3e14-4acc-a83c-f474c599fa8a 61 fields · synced Jul 29, 2026