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Sonosite PX
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref P31060-01Model SONOSITE PX ULTRASOUND SYSTEMRef P31060-03Ref P31060-04Ref P31108-01Model SONOSITE PX STAND,INDIARef P25000-45Ref P25000-15
Identity
- Trade Name
- Sonosite PX EUDAMEDFDA UDISonosite PX Stand EUDAMED
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- SONOSITE PX ULTRASOUND SYSTEM EUDAMEDSONOSITE PX STAND,INDIA EUDAMEDDiagnostic ultrasound system FDA UDIDiagnostic ultrasound system. FDA UDI
- Model / Reference
- SONOSITE PX ULTRASOUND SYSTEM EUDAMEDP31060-01 EUDAMEDP31060-03 EUDAMEDP31060-04 EUDAMEDSONOSITE PX STAND,INDIA EUDAMEDP31108-01 EUDAMEDP25000-45 EUDAMEDFDA UDIP25000-15 EUDAMEDFDA UDI
- Description
- Diagnostic ultrasound system FDA UDIDiagnostic ultrasound system. FDA UDI
Identifiers
- Catalog Number
- P25000 FDA UDI
- Primary DI / UDI-DI
- 00841517108182 EUDAMED00841517111427 EUDAMED00841517111434 EUDAMED00841517108281 EUDAMED00841517110758 EUDAMEDFDA UDI00841517105891 EUDAMEDFDA UDI
- Basic UDI-DI
- 08415171PX8P EUDAMEDB-00841517108281 EUDAMED
- FDA Product Code
- ITX FDA UDIIYO FDA UDIIYN FDA UDIOIJ FDA UDI
- EMDN Code
- Z11040103 PORTABLE ULTRASOUND SCANNERS EUDAMEDZ1104018099 ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER EUDAMED
- GMDN Term
- General-purpose ultrasound imaging system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1570 FDA UDI892.1560 FDA UDI892.1550 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 PX by Fujifilm Sonosite, Inc. — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 08415171PX8P | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 08415171PX8P | 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 (8)
- EUDAMED f1c6bd10-71ee-4171-b916-3346281d0226 61 fields · synced Sep 18, 2026
- EUDAMED 48efb3e8-f74e-4bdb-a19c-a46d7e1b46e8 61 fields · synced May 17, 2026
- EUDAMED f0dac35a-0524-4968-849a-b353bc25cf9f 61 fields · synced May 18, 2026
- EUDAMED b83ff70b-1314-430a-bebc-659e476cac6b 61 fields · synced May 19, 2026
- FDA UDI e318a076-c9ad-4237-8071-60c9db061244 36 fields · synced May 29, 2026
- FDA UDI 69c3d5b1-5441-4f5f-a4af-f4157a3a7430 36 fields · synced May 30, 2026
- EUDAMED 89732c93-a9be-4a19-a3f6-f6f307fd83ce 61 fields · synced Jul 8, 2026
- EUDAMED 1507f4c5-ecfd-415d-988c-4d0d94bca5db 61 fields · synced Jul 16, 2026