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Pr54
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref PR54Model TRANSCUTANEOUS ULTRASOUND SECTOR PROBES (PHASED ARRAY)
by Sonoscanner
Identity
- Trade Name
- PR54 EUDAMEDU-Lite FDA UDI
- Generic Name
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
- Device Name
- Phased Array Probe 1.5-4 Mhz FDA UDI
- Model / Reference
- TRANSCUTANEOUS ULTRASOUND SECTOR PROBES (PHASED ARRAY) EUDAMEDPR54 EUDAMEDFDA UDI
- Description
- Phased Array Probe 1.5-4 Mhz FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03701104600093 EUDAMEDFDA UDI
- Basic UDI-DI
- 37011046PAUSPROBES2N EUDAMED
- Direct Marketing DI
- 03701104600093 EUDAMED
- 510(k) Number
- K171164 FDA UDI
- FDA Product Code
- ITX FDA UDI
- EMDN Code
- Z110402010301 TRANSCUTANEOUS ULTRASOUND SECTOR PROBES (PHASED ARRAY), TWO–DIMENSIONAL 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
- France 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
Pr54 by Sonoscanner — Class IIa — 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 | 37011046PAUSPROBES2N | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Sonoscanner
- EUDAMED SRN
- FR-MF-000002220
Sources (2)
- EUDAMED f2568f19-f60e-4e6d-a4a6-093e62c73160 61 fields · synced Jun 19, 2026
- FDA UDI f41af8ed-f9e1-43bb-8aae-f46c222d5bb6 34 fields · synced May 30, 2026