Identity
- Trade Name
- MediByte Software EUDAMED
- Device Name
- MediByte EUDAMED
- Model / Reference
- MP-8 EUDAMED2000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- B140200090 EUDAMED
- Basic UDI-DI
- ++B140MediByte4Q EUDAMED
- Direct Marketing DI
- B140200090 EUDAMED
- EMDN Code
- Z12100582 POLYSOMNOGRAPHY INSTRUMENTS - SOFTWARE ACCESSORIES 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 Software by Braebon Medical Corporation — Class IIa — 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 | ++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 (1)
- EUDAMED e3330677-78b1-4d4d-a93e-a574d3ce05aa 61 fields · synced Jun 18, 2026