Identity
- Trade Name
- L 3-11 EUDAMEDFDA UDI
- Generic Name
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
- Device Name
- Linear / Low Frequency EUDAMEDL 3-11 EUDAMED
- Model / Reference
- 120000014 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08056304452924 EUDAMEDFDA UDI
- Basic UDI-DI
- 805630445ESA.PR0000008.T8 EUDAMEDB-08056304452924 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 3-11 by Esaote S.p.A. — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Extracorporeal ultrasound imaging transducer, hand-held.
- 6C2 Transducer — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
- Biim Android App, P1.3 — Biim Ultrasound AS · Class II
- C6-2 Transducer — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
- Battery Charger AU, Biim Ultrasound — Biim Ultrasound AS · Class II
- SonoScape — SONOSCAPE MEDICAL CORP. · Class II
- 4C1 Transducer — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
- UST-5419 — FUJIFILM Corporation · Class II
- P4-12 — SAMSUNG MEDISON CO., LTD · Class II
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.PR0000008.T8 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 805630445ESA.PR0000008.T8 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Esaote S.p.A.
- EUDAMED SRN
- IT-MF-000019024
Sources (3)
- EUDAMED df3ea2bb-f54c-4fa0-bedb-9212c79e8078 61 fields · synced Jul 19, 2026
- EUDAMED 365807fb-feb9-4af0-8fa6-a566e626a155 61 fields · synced May 17, 2026
- FDA UDI 13974dfc-23f0-4b87-90e6-a9e73c18070e 33 fields · synced May 30, 2026