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Sonosite ZX Portable System
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref P32000-20Model PORTABLE SYSTEM, SONOSITE ZXRef P32502-01Ref P32502-02
Identity
- Trade Name
- Sonosite ZX Portable System EUDAMEDFDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- PORTABLE SYSTEM, SONOSITE ZX EUDAMEDDiagnostic Ultrasound System FDA UDI
- Model / Reference
- PORTABLE SYSTEM, SONOSITE ZX EUDAMEDP32000-20 EUDAMEDFDA UDIP32502-01 EUDAMEDP32502-02 EUDAMED
- Description
- Diagnostic Ultrasound System FDA UDI
Identifiers
- Catalog Number
- P32000 FDA UDI
- Primary DI / UDI-DI
- 00841517108496 EUDAMEDFDA UDI00841517110086 EUDAMED00841517111366 EUDAMED
- Basic UDI-DI
- 08415171ZX9M EUDAMEDB-00841517110086 EUDAMED
- 510(k) Number
- K213763 FDA UDI
- FDA Product Code
- IYN 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
- 892.1550 FDA UDI892.1560 FDA UDI
- Market of Registration
- Poland 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 ZX Portable System by Fujifilm Sonosite, Inc. — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08415171ZX9M | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | 08415171ZX9M | 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 (4)
- EUDAMED 1907743a-4dfe-4297-9fae-3c6ae85a6215 61 fields · synced Aug 2, 2026
- EUDAMED 26886c42-90c4-4680-b4a4-6ead10db90c9 61 fields · synced May 16, 2026
- EUDAMED bc1d5256-8414-41f5-9629-269f1d72a3d1 61 fields · synced May 18, 2026
- FDA UDI 0a86ae08-860a-47bb-a84e-f0506416604c 36 fields · synced May 30, 2026