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SonoSite LX
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref P28354-48Model SONOSITE LX ULTRASOUND SYSTEM
Identity
- Trade Name
- SonoSite LX EUDAMEDFDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- SONOSITE LX ULTRASOUND SYSTEM EUDAMEDDiagnostic Ultrasound System FDA UDI
- Model / Reference
- SONOSITE LX ULTRASOUND SYSTEM EUDAMEDP28354-48 EUDAMEDFDA UDI
- Description
- Diagnostic Ultrasound System FDA UDI
Identifiers
- Catalog Number
- P28354 FDA UDI
- Primary DI / UDI-DI
- 00841517110826 EUDAMEDFDA UDI
- Basic UDI-DI
- 08415171LX8B EUDAMED
- 510(k) Number
- K233597 FDA UDI
- FDA Product Code
- ITX FDA UDIIYN FDA UDIIYO FDA UDI
- EMDN Code
- Z11040103 PORTABLE ULTRASOUND SCANNERS EUDAMED
- GMDN Term
- General-purpose ultrasound imaging system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1570 FDA UDI892.1550 FDA UDI892.1560 FDA UDI
- Market of Registration
- Austria 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
SonoSite LX by Fujifilm Sonosite, Inc. — 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 | 08415171LX8B | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Fujifilm Sonosite, Inc.
- EUDAMED SRN
- US-MF-000001075
- Authorised Representative
- Fujifilm Sonosite B.V. NL-AR-000000046
Sources (2)
- EUDAMED 62d9181e-e5c0-46cb-9fcf-62b5c8a4d122 61 fields · synced May 30, 2026
- FDA UDI 7503311f-601d-41fa-9361-c980d6ce7cf9 36 fields · synced May 30, 2026