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Sonosite PX Stand Head
EUDAMEDFDA UDIClass I (EU MDR)
Ref P25001-26Model SONOSITE PX STAND HEAD, 2.0Ref P25001-25RModel SERVICE EXCHANGE, SONOSITE PX STAND HEAD, 2.0
Identity
- Trade Name
- Sonosite PX Stand Head EUDAMEDFDA UDI
- Generic Name
- Electromechanical device/system transport trolley FDA UDI
- Device Name
- SONOSITE PX STAND HEAD, 2.0 EUDAMEDSERVICE EXCHANGE, SONOSITE PX STAND HEAD, 2.0 EUDAMEDDIAGNOSTIC ULTRAOSUND SYSTEM ACCESSORY FDA UDI
- Model / Reference
- SONOSITE PX STAND HEAD, 2.0 EUDAMEDP25001-26 EUDAMEDFDA UDISERVICE EXCHANGE, SONOSITE PX STAND HEAD, 2.0 EUDAMEDP25001-25R EUDAMED
- Description
- DIAGNOSTIC ULTRAOSUND SYSTEM ACCESSORY FDA UDI
Identifiers
- Catalog Number
- P25001 FDA UDI
- Primary DI / UDI-DI
- 00841517109981 EUDAMEDFDA UDI00841517110116 EUDAMED
- Basic UDI-DI
- B-00841517109981 EUDAMEDB-00841517110116 EUDAMED
- FDA Product Code
- IYO FDA UDIITX FDA UDIIYN FDA UDI
- EMDN Code
- Z1104018099 ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER EUDAMED
- GMDN Term
- Electromechanical device/system transport trolley FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1560 FDA UDI892.1570 FDA UDI892.1550 FDA UDI
- 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 Stand Head by Fujifilm Sonosite, Inc. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00841517109981 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 (3)
- EUDAMED 4b8ad12e-6fb1-4361-a1bb-6353eebb6f24 61 fields · synced Oct 6, 2026
- EUDAMED 323e3a7a-9cdd-4adf-9653-23f5901b1fea 61 fields · synced May 18, 2026
- FDA UDI 0c476b08-7802-4bb1-8b7e-f6550ccf710c 36 fields · synced May 30, 2026