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SonoSite LX
EUDAMEDFDA UDIClass I (EU MDR)
Ref P31093-17Model SONOSITE MICROPHONE ACCESSORY
Identity
- Trade Name
- SonoSite LX EUDAMEDFDA UDI
- Generic Name
- Freestanding microphone FDA UDI
- Device Name
- SONOSITE MICROPHONE ACCESSORY EUDAMEDDiagnostic ultrasound system accessory FDA UDI
- Model / Reference
- SONOSITE MICROPHONE ACCESSORY EUDAMEDP31093-17 EUDAMEDFDA UDI
- Description
- Diagnostic ultrasound system accessory FDA UDI
Identifiers
- Catalog Number
- P31093 FDA UDI
- Primary DI / UDI-DI
- 00841517110024 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00841517110024 EUDAMED
- 510(k) Number
- K233597 FDA UDI
- FDA Product Code
- ITX FDA UDIIYO FDA UDIIYN FDA UDI
- EMDN Code
- Z1104018099 ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER EUDAMED
- GMDN Term
- Freestanding microphone FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1570 FDA UDI892.1560 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 LX 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-00841517110024 | 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 (2)
- EUDAMED 451cb885-eb98-4633-a826-0bd38a5dd911 61 fields · synced May 30, 2026
- FDA UDI 2fa022dc-a0de-4e86-a68b-8cfdfa6604cf 36 fields · synced May 30, 2026