Identity
- Trade Name
- Kosmos EUDAMEDKosmos Torso-One – USB EUDAMEDKosmos Torso-One - USB FDA UDI
- Generic Name
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
- Device Name
- Kosmos EUDAMED
- Model / Reference
- P008791 EUDAMEDP006632 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 09353278000878 EUDAMED09353278000502 EUDAMEDFDA UDI
- Basic UDI-DI
- 93532780KOSMOSWH EUDAMED
- 510(k) Number
- K193518 FDA UDI
- FDA Product Code
- ITX FDA UDI
- EMDN Code
- Z11040106 HANDHELD ULTRASOUND SCANNERS EUDAMEDZ110402010301 TRANSCUTANEOUS ULTRASOUND SECTOR PROBES (PHASED ARRAY), TWO–DIMENSIONAL EUDAMED
- GMDN Term
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- Market of Registration
- Denmark EUDAMEDMalta 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
Kosmos 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 (3)
- EUDAMED 9979147c-6104-4a6c-9aca-f143b7900171 61 fields · synced Sep 18, 2026
- EUDAMED 9548b82c-1170-4203-ad29-b25839812ade 61 fields · synced May 18, 2026
- FDA UDI 1e639592-afd8-419e-b953-d05606063149 33 fields · synced May 27, 2026