Identity
- Trade Name
- MediByte EUDAMED
- Device Name
- MediByte EUDAMED
- Model / Reference
- MP8 EUDAMEDMP-8 EUDAMED
Identifiers
- Primary DI / UDI-DI
- B140MP80 EUDAMED
- Basic UDI-DI
- B-B140MP80 EUDAMED++B140MediByte4Q EUDAMED
- Direct Marketing DI
- B140MP80 EUDAMED
- EMDN Code
- Z12100501 POLYSOMNOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
MediByte by Braebon Medical Corporation — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-B140MP80 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-B140MP80 | Class IIa | Active |
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Manufacturer
- Manufacturer
- BRAEBON Medical Corporation
- EUDAMED SRN
- CA-MF-000002190
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (2)
- EUDAMED d7411e49-80e5-406b-b343-508c223efbdc 61 fields · synced Oct 7, 2026
- EUDAMED 565e08f4-5450-43c1-9cb4-dd1b5716e836 61 fields · synced May 18, 2026