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SonoSite Stand
EUDAMEDFDA UDIClass I (EU MDR)
Ref P31107-02Model SONOSITE STANDRef P29455-02Ref P30382-02Ref P30384-02
Identity
- Trade Name
- SonoSite Stand EUDAMEDSonosite PX Stand Head FDA UDI
- Generic Name
- Electromechanical device/system transport trolley FDA UDI
- Device Name
- SONOSITE STAND EUDAMEDDIANOSTIC ULTRASOUND SYSTEM ACCESSORY FDA UDI
- Model / Reference
- SONOSITE STAND EUDAMEDP31107-02 EUDAMEDP29455-02 EUDAMEDFDA UDIP30382-02 EUDAMEDP30384-02 EUDAMED
- Description
- DIANOSTIC ULTRASOUND SYSTEM ACCESSORY FDA UDI
Identifiers
- Catalog Number
- P29455 FDA UDI
- Primary DI / UDI-DI
- 00841517111281 EUDAMED00841517109974 EUDAMEDFDA UDI00841517111267 EUDAMED00841517111274 EUDAMED
- Basic UDI-DI
- 08415171STNDMX EUDAMED
- FDA Product Code
- ITX FDA UDIIYN FDA UDIIYO 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
- 892.1570 FDA UDI892.1550 FDA UDI892.1560 FDA UDI
- Market of Registration
- Austria EUDAMEDItaly 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 Stand by Fujifilm Sonosite, Inc. — Class I — 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 | 08415171STNDMX | 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 (5)
- EUDAMED a225b1d4-c86b-4bef-b0b4-c882b0b54d2b 61 fields · synced Jul 21, 2026
- EUDAMED f0bce893-55fc-424a-b672-d0c9ff53e3c8 61 fields · synced May 18, 2026
- EUDAMED 831e9cdf-087a-497d-b7b3-cdc0022d1343 61 fields · synced May 18, 2026
- EUDAMED 5f71d68d-3458-42c4-b02f-5e857b816485 61 fields · synced May 19, 2026
- FDA UDI 2217cd24-3716-4c1c-9a20-258fce9ba3bd 36 fields · synced May 30, 2026