Identity
- Trade Name
- LA523 EUDAMEDFDA UDI
- Generic Name
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
- Device Name
- LA523 EUDAMEDLinear / Medium Frequency EUDAMED
- Model / Reference
- 9600156000 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08056304451934 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08056304451934 EUDAMED805630445ESA.PR0000009.TB EUDAMED
- 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
La523 by Esaote S.p.A. — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08056304451934 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08056304451934 | 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 87f840b7-3cd6-4306-aac0-3b9302705539 61 fields · synced Jul 13, 2026
- EUDAMED 1e2e844a-315e-47bc-897c-a25de70ad969 61 fields · synced May 17, 2026
- FDA UDI 086f8f58-232f-43e0-9c1d-70a32856f63d 32 fields · synced May 30, 2026