Identity
- Trade Name
- MediByte Jr EUDAMED
- Device Name
- MediByte EUDAMEDMediByte Jr EUDAMED
- Model / Reference
- MP-8 EUDAMEDMBJR EUDAMED
Identifiers
- Primary DI / UDI-DI
- B140MBJR0 EUDAMED
- Basic UDI-DI
- ++B140MediByte4Q EUDAMEDB-B140MBJR0 EUDAMED
- Direct Marketing DI
- B140MBJR0 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 Jr by Braebon Medical Corporation — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | ++B140MediByte4Q | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | ++B140MediByte4Q | Class IIa | Active |
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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 7f244a3c-748a-4aba-979a-e82404448e01 61 fields · synced Oct 6, 2026
- EUDAMED 2c461f3f-86a6-499a-b0f3-7cbeaeff8f4e 61 fields · synced May 17, 2026