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T Lite
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref T LITEModel HANDHELD ULTRASOUND SCANNERS
by Sonoscanner
Identity
- Trade Name
- T Lite EUDAMEDT-Lite FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- Handheld Ultrasound Scanner T-Lite with exchangeable probes FDA UDI
- Model / Reference
- HANDHELD ULTRASOUND SCANNERS EUDAMEDT LITE EUDAMEDInitial FDA UDI
- Description
- Handheld Ultrasound Scanner T-Lite with exchangeable probes FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03701104600116 EUDAMEDFDA UDI
- Basic UDI-DI
- 37011046USHANDHELDTS EUDAMED
- Direct Marketing DI
- 03701104600116 EUDAMED
- 510(k) Number
- K201988 FDA UDI
- FDA Product Code
- IYN FDA UDIITX FDA UDIIYO FDA UDI
- EMDN Code
- Z11040106 HANDHELD 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 UDI892.1570 FDA UDI892.1560 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
T Lite 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 | 37011046USHANDHELDTS | 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 7dcc202d-d4c8-4c6d-a6de-06bbeecdc14e 61 fields · synced Oct 6, 2026
- FDA UDI 9455ca01-eaf4-43e7-ad0a-e4126c2bc8c0 34 fields · synced May 30, 2026