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UHF48 Transducer
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 51415-50AModel UHF48: 48 MHZ ULTRA HIGH-FREQUENCY CLINICAL TRANSDUCER
Identity
- Trade Name
- UHF48 Transducer EUDAMEDFDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- UHF48: 48 MHZ ULTRA HIGH-FREQUENCY CLINICAL TRANSDUCER EUDAMEDDiagnostic Ultrasound Transducer FDA UDI
- Model / Reference
- UHF48: 48 MHZ ULTRA HIGH-FREQUENCY CLINICAL TRANSDUCER EUDAMED51415-50A EUDAMEDFDA UDI
- Description
- Diagnostic Ultrasound Transducer FDA UDI
Identifiers
- Catalog Number
- 51415 FDA UDI
- Primary DI / UDI-DI
- 00841517104689 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00841517104689 EUDAMED
- 510(k) Number
- K160674 FDA UDI
- FDA Product Code
- IYO FDA UDIITX FDA UDIIYN FDA UDI
- EMDN Code
- Z110402010101 TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES EUDAMED
- GMDN Term
- General-purpose ultrasound imaging system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1560 FDA UDI892.1570 FDA UDI892.1550 FDA UDI
- Market of Registration
- Italy 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
UHF48 Transducer by Fujifilm Sonosite, Inc. — Class IIa — 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-00841517104689 | 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 (2)
- EUDAMED b34b7f42-cf16-457c-893f-c8c6adb81b70 61 fields · synced Jul 19, 2026
- FDA UDI cc450614-5c56-4261-bff5-b3f4d48326bd 37 fields · synced May 30, 2026