← Back to catalogue
Ultima Snore Microphone for MediByte with Thermistor Input
EUDAMEDFDA UDIClass I (EU MDR)
Ref 8541Model 0540
Identity
- Trade Name
- Ultima Snore Microphone for MediByte with Thermistor Input EUDAMEDBRAEBON Ultima Snore Microphone for MediByte with Thermistor Input FDA UDI
- Generic Name
- Freestanding microphone FDA UDI
- Device Name
- Ultima Snore Microphone EUDAMEDFor use during sleep disorder studies as a measure of snoring for recording with a MediByte. FDA UDI
- Model / Reference
- 0540 EUDAMED8541 EUDAMEDFDA UDI
- Description
- For use during sleep disorder studies as a measure of snoring for recording with a MediByte. FDA UDI
Identifiers
- Catalog Number
- 8541 FDA UDI
- Primary DI / UDI-DI
- B14085410 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B140Snoring56 EUDAMED
- Direct Marketing DI
- B14085410 EUDAMED
- 510(k) Number
- K020312 FDA UDI
- FDA Product Code
- MNR FDA UDI
- EMDN Code
- Z12100580 POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Freestanding microphone FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.2375 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Ultima Snore Microphone for MediByte with Thermistor Input by Braebon Medical Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | ++B140Snoring56 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BRAEBON Medical Corporation
- EUDAMED SRN
- CA-MF-000002190
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (2)
- EUDAMED abfea403-749f-4338-98c5-2ce703902efa 61 fields · synced Oct 6, 2026
- FDA UDI 0ca52c23-b32c-4149-83d4-ffb8a010514f 37 fields · synced May 30, 2026