Identity
- Trade Name
- IL 4-13 EUDAMEDFDA UDI
- Generic Name
- Surgical ultrasound imaging transducer FDA UDI
- Device Name
- IL 4-13 EUDAMEDIntraoperative EUDAMED
- Model / Reference
- 120000027 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08056304451361 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08056304451361 EUDAMED805630445ESA.PR0000006.T2 EUDAMED
- FDA Product Code
- ITX FDA UDI
- EMDN Code
- Z11040299 ULTRASOUND PROBES – OTHER EUDAMEDZ110402010101 TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES EUDAMED
- GMDN Term
- Surgical ultrasound imaging transducer 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
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
Hydrogen Peroxide FDA UDI
Il 4-13 by Esaote S.p.A. — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08056304451361 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08056304451361 | 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 e132b9be-2324-4f49-8d70-0df3476fec0e 61 fields · synced Jun 20, 2026
- EUDAMED 0b095c63-d7bf-4a8a-8d1e-6c6d152284bc 61 fields · synced May 19, 2026
- FDA UDI e61faa1d-6ce7-409e-ab71-452b36562d2e 32 fields · synced May 30, 2026