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Ultima Snoring Sensor With Keyhole Connector
EUDAMEDFDA UDIClass I (EU MDR)
Ref 0543Model 0540
Identity
- Trade Name
- ULTIMA SNORING SENSOR WITH KEYHOLE CONNECTOR EUDAMEDBRAEBON Ultima Snoring Sensor with Keyhole Connector 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 onto a data acquisition system. FDA UDI
- Model / Reference
- 0540 EUDAMED0543 EUDAMEDFDA UDI
- Description
- For use during sleep disorder studies as a measure of snoring for recording onto a data acquisition system. FDA UDI
Identifiers
- Catalog Number
- 0543 FDA UDI
- Primary DI / UDI-DI
- B14005430 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B140Snoring56 EUDAMED
- Direct Marketing DI
- B14005430 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 Snoring Sensor With Keyhole Connector 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 |
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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 a0b2875e-cedc-487c-97a6-b7e872018c3b 61 fields · synced Oct 6, 2026
- FDA UDI e2d57606-322d-43a9-8418-a56a7616bcab 37 fields · synced May 30, 2026