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Microphone for high Sampling Rate (Snore)
EUDAMEDClass IIa (EU MDR)
Ref SEN606BModel Snoring detection sensor
Identity
- Trade Name
- Microphone for high Sampling Rate (Snore) EUDAMED
- Model / Reference
- Snoring detection sensor EUDAMEDSEN606B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250413401161 EUDAMED
- Basic UDI-DI
- 42504134MicUW EUDAMED
- EMDN Code
- Z1203020280 MULTI-PARAMETER MONITORS - HARDWARE 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
Microphone for high Sampling Rate (Snore) by SOMNOmedics AG — 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 | 42504134MicUW | Class IIa | Active |
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Manufacturer
- Manufacturer
- SOMNOmedics AG
- EUDAMED SRN
- DE-MF-000006921
Sources (1)
- EUDAMED f975d7ef-65ec-443a-8b2d-9ea79d01a344 61 fields · synced Jul 8, 2026