Identity
- Trade Name
- Q-SNOR SENSOR EUDAMEDBRAEBON Q-Snor Kit FDA UDI
- Generic Name
- Freestanding microphone FDA UDI
- Device Name
- Q-Snore Kit EUDAMEDComplete Q-Snor kit for use during sleep disorder studies as a measure of snoring for recording onto a data acquisition system. Kit contains Q-Snor interface module and Q-Snor Microphone. FDA UDI
- Model / Reference
- 0546 EUDAMEDFDA UDI
- Description
- Complete Q-Snor kit for use during sleep disorder studies as a measure of snoring for recording onto a data acquisition system. Kit contains Q-Snor interface module and Q-Snor Microphone. FDA UDI
Identifiers
- Catalog Number
- 0546 FDA UDI
- Primary DI / UDI-DI
- B14005460 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B140QSnorD6 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Q-Snor Sensor by Braebon Medical Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | ++B140QSnorD6 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 d1443e8d-c3d0-4ea7-9e23-a35f966010fe 61 fields · synced Jun 19, 2026
- FDA UDI d119c4d9-dd56-42af-94b9-904127502d15 37 fields · synced May 30, 2026