Identity
- Trade Name
- L 8-24 EUDAMEDFDA UDI
- Generic Name
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
- Device Name
- Linear / High and Ultra High Frequency EUDAMEDL 8-24 EUDAMED
- Model / Reference
- 120000041 EUDAMED120000037 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08056304453068 EUDAMEDFDA UDI
- Basic UDI-DI
- 805630445ESA.PR0000010.SM EUDAMEDB-08056304453068 EUDAMED
- 510(k) Number
- K173291 FDA UDI
- FDA Product Code
- ITX FDA UDI
- EMDN Code
- Z110402010101 TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES 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
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Extracorporeal ultrasound imaging transducer, hand-held
L 8-24 by Esaote S.p.A. — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 805630445ESA.PR0000010.SM | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 805630445ESA.PR0000010.SM | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Esaote S.p.A.
- EUDAMED SRN
- IT-MF-000019024
Sources (3)
- EUDAMED 24d09231-0a4e-4337-872b-a613724bebf6 61 fields · synced Jul 24, 2026
- EUDAMED 365dfee4-dcd8-413f-b39b-1ad60240c879 61 fields · synced May 18, 2026
- FDA UDI 11cfe677-b7c5-4e57-aab3-59b9fc8a6791 33 fields · synced May 30, 2026