← Back to catalogue
Microphone for Snoring detection
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref SEN602Model Snoring detection sensorRef SEN604
Identity
- Trade Name
- Microphone for Snoring detection EUDAMEDFDA UDI
- Generic Name
- Polysomnograph FDA UDI
- Model / Reference
- Snoring detection sensor EUDAMEDSEN602 EUDAMEDFDA UDISEN604 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250413400362 EUDAMEDFDA UDI04250413400584 EUDAMED
- Basic UDI-DI
- 42504134MicUW EUDAMED
- 510(k) Number
- K071556 FDA UDI
- FDA Product Code
- MNR FDA UDI
- EMDN Code
- Z1203020280 MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Polysomnograph FDA UDI
Classification
- Device Class
- Class IIa 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Microphone for Snoring detection by SOMNOmedics AG — Class IIa — 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 | 42504134MicUW | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- SOMNOmedics AG
- EUDAMED SRN
- DE-MF-000006921
Sources (3)
- EUDAMED 57802a13-7cf1-4b25-b2a2-297e18007c6e 61 fields · synced Jul 30, 2026
- EUDAMED 85a11656-e68c-4803-898b-2349ef31dbd1 61 fields · synced May 17, 2026
- FDA UDI c3bb002a-1aa7-49c6-a286-505da988e30c 33 fields · synced May 30, 2026