Identity
- Trade Name
- Kosmos OTS iOS EUDAMEDFDA UDI
- Generic Name
- Ultrasound imaging system application software FDA UDI
- Device Name
- Kosmos EUDAMEDKOSMOS OTS iOS SOFTWARE PACKAGE [2.X] FDA UDI
- Model / Reference
- P007944 EUDAMEDFDA UDI
- Description
- KOSMOS OTS iOS SOFTWARE PACKAGE [2.X] FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09353278000762 EUDAMEDFDA UDI
- Basic UDI-DI
- 93532780KOSMOSWH EUDAMED
- FDA Product Code
- IYO FDA UDIIYN FDA UDI
- EMDN Code
- Z11040106 HANDHELD ULTRASOUND SCANNERS EUDAMED
- GMDN Term
- Ultrasound imaging system application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1560 FDA UDI892.1550 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Kosmos OTS iOS 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 623a92d4-00c2-4c81-bc50-607ef5ecf21e 61 fields · synced Jul 27, 2026
- FDA UDI bcdd2976-41de-4c79-8b73-15811c4d96ed 34 fields · synced May 30, 2026