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U Lite Exp
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref U LITE EXPModel HANDHELD ULTRASOUND SCANNERS
by Sonoscanner
Identity
- Trade Name
- U LITE EXP EUDAMEDU-Lite FDA UDI
- Generic Name
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
- Device Name
- Handheld Ultrasound Scanner with exchangeable probes FDA UDI
- Model / Reference
- HANDHELD ULTRASOUND SCANNERS EUDAMEDU LITE EXP EUDAMEDEXP FDA UDI
- Description
- Handheld Ultrasound Scanner with exchangeable probes FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03701104600048 EUDAMEDFDA UDI
- Basic UDI-DI
- 37011046USHANDHELDTS EUDAMED
- Direct Marketing DI
- 03701104600048 EUDAMED
- 510(k) Number
- K171164 FDA UDI
- FDA Product Code
- IYO FDA UDIIYN FDA UDI
- EMDN Code
- Z11040106 HANDHELD ULTRASOUND SCANNERS EUDAMED
- GMDN Term
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1560 FDA UDI892.1550 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
U Lite Exp by Sonoscanner — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K171164 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 37011046USHANDHELDTS | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sonoscanner
- EUDAMED SRN
- FR-MF-000002220
Sources (3)
- EUDAMED f237b7f8-ad5d-40db-8cc2-e121a87a0c8e 61 fields · synced Jun 19, 2026
- FDA UDI 885b2bb0-deb9-49e4-9cc2-bb2f48c74293 34 fields · synced May 30, 2026
- FDA 510(k) K171164 1 fields · synced May 18, 2026