Identity
- Trade Name
- SB3123 EUDAMEDFDA UDI
- Generic Name
- Rectal ultrasound imaging system transducer FDA UDI
- Device Name
- Volumetric EUDAMEDSB3123 EUDAMED
- Model / Reference
- 122001900 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08056304451835 EUDAMEDFDA UDI
- Basic UDI-DI
- 805630445ESA.PR0000015.T4 EUDAMEDB-08056304451835 EUDAMED
- FDA Product Code
- ITX FDA UDI
- EMDN Code
- Z110402010202 CURVILINEAR TRANSCUTANEOUS MULTIDIMENSIONAL ULTRASOUND PROBES (CONVEX–ARRAY) EUDAMEDZ1104020202 ENDOCAVITARY ULTRASOUND PROBES, MULTIDIMENSIONAL EUDAMED
- GMDN Term
- Rectal ultrasound imaging system 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
Sb3123 by Esaote S.p.A. — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 805630445ESA.PR0000015.T4 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 805630445ESA.PR0000015.T4 | 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 65f571e7-712d-4fc3-926b-6add43a5f331 61 fields · synced Jul 18, 2026
- EUDAMED 976aa809-4f89-4d1b-a760-6f3af688e6e6 61 fields · synced May 18, 2026
- FDA UDI 151aec4c-deac-48a9-a72b-6d204acef8ce 32 fields · synced May 30, 2026