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Kosmos Accessories-International
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref P006105
by EchoNous
Identity
- Trade Name
- Kosmos Accessories-International EUDAMEDKosmos Accessories - International FDA UDI
- Generic Name
- Electrocardiograph, professional, single-channel FDA UDI
- Device Name
- Kosmos EUDAMEDKosmos Binaural Headset, ECG Patient Cable, Bridge Stand FDA UDI
- Model / Reference
- P006105 EUDAMEDFDA UDI
- Description
- Kosmos Binaural Headset, ECG Patient Cable, Bridge Stand FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09353278000250 EUDAMEDFDA UDI
- Basic UDI-DI
- 93532780KOSMOSWH EUDAMED
- Direct Marketing DI
- 09353278000250 EUDAMED
- 510(k) Number
- K193518 FDA UDI
- FDA Product Code
- DQD FDA UDIDPS FDA UDI
- EMDN Code
- C9080 CARDIOCIRCULATORY SYSTEM DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Electrocardiograph, professional, single-channel FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1875 FDA UDI870.2340 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 Accessories-International 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 3f6240c3-d4e5-445a-9a87-504b488721f9 61 fields · synced Jul 11, 2026
- FDA UDI 4dc4771a-5544-468d-afeb-bcb09cd65165 34 fields · synced May 29, 2026