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Kosmos Binaural Headset
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref P006115
by EchoNous
Identity
- Trade Name
- Kosmos Binaural Headset EUDAMEDFDA UDI
- Generic Name
- Electronic acoustic stethoscope FDA UDI
- Device Name
- Kosmos EUDAMEDElectronic stethoscope FDA UDI
- Model / Reference
- P006115 EUDAMEDFDA UDI
- Description
- Electronic stethoscope FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09353278000212 EUDAMEDFDA UDI
- Basic UDI-DI
- 93532780KOSMOSWH EUDAMED
- 510(k) Number
- K193518 FDA UDI
- FDA Product Code
- DQD FDA UDI
- EMDN Code
- C9005 PHONENDOSCOPES AND STETHOSCOPES EUDAMED
- GMDN Term
- Electronic acoustic stethoscope FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1875 FDA UDI
- Market of Registration
- Malta 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Kosmos Binaural Headset by EchoNous — 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 | 93532780KOSMOSWH | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- EchoNous
- EUDAMED SRN
- US-MF-000004161
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 58db7ee1-1ea9-4e51-86a4-22a1514ae1d7 61 fields · synced Jun 19, 2026
- FDA UDI 59082ece-7499-49e7-8e34-1a02151a3f44 34 fields · synced May 29, 2026