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Multi-frequency Phased-array Ultrasound Probe
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref P5FNModel P3F14K、P3F14C、P5FN、TR2-14、TR5-14
Identity
- Trade Name
- SIUI FDA UDI
- Generic Name
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
- Device Name
- Multi-frequency Phased-array Ultrasound Probe EUDAMEDPhased Array Transducer FDA UDI
- Model / Reference
- P3F14K、P3F14C、P5FN、TR2-14、TR5-14 EUDAMEDP5FN EUDAMEDFDA UDI
- Description
- Phased Array Transducer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06938396494070 EUDAMEDFDA UDI
- Basic UDI-DI
- 693839640010042897K00009N EUDAMED
- FDA Product Code
- ITX FDA UDI
- EMDN Code
- Z11040299 ULTRASOUND PROBES – OTHER EUDAMED
- GMDN Term
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- Market of Registration
- Germany 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
No
FDA UDI
MR Unsafe FDA UDI
Multi-frequency Phased-array Ultrasound Probe by Shantou Institute of Ultrasonic Instruments Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 693839640010042897K00009N | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- EUDAMED SRN
- CN-MF-000010834
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 04919992-c811-4bd5-aad6-d6f5e3bceb21 61 fields · synced Oct 7, 2026
- FDA UDI d382d781-b2c5-422c-a66b-0d96f3db780d 34 fields · synced May 29, 2026