Identity
- Trade Name
- VuPad EUDAMEDVuPad Ophthalmic Ultrasound System FDA UDI
- Generic Name
- Ophthalmic ultrasound imaging system FDA UDI
- Device Name
- VuPad Ophthalmic Ultrasound EUDAMEDThe VuPad Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biometric device intended for use in ophthalmic applications.The system includes capabilities for B-Scan and UBM (high frequency B-scan). The device is used by coupling the probe/transducer to the eye either by direct contact or immersion methods. The VuPad B-Scan mode produces a live, two-dimensional image to facilitate the identification and measurement of ocular pathologies in the posterior chamber of the eye. The system is a stand-alone system that runs on a Windows 10 platform and may be networked for interface with electronic medical records systems and printers. The system is provided with the portable B-Scan/UBM tablet, 12 MHz B-probe, water-path probe with 35 MHz transducer, built-in probe holders, foot switch and user manual. FDA UDI
- Model / Reference
- VuPad B/UBM EUDAMEDFDA UDIBU.580 EUDAMED
- Description
- The VuPad Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biometric device intended for use in ophthalmic applications.The system includes capabilities for B-Scan and UBM (high frequency B-scan). The device is used by coupling the probe/transducer to the eye either by direct contact or immersion methods. The VuPad B-Scan mode produces a live, two-dimensional image to facilitate the identification and measurement of ocular pathologies in the posterior chamber of the eye. The system is a stand-alone system that runs on a Windows 10 platform and may be networked for interface with electronic medical records systems and printers. The system is provided with the portable B-Scan/UBM tablet, 12 MHz B-probe, water-path probe with 35 MHz transducer, built-in probe holders, foot switch and user manual. FDA UDI
Identifiers
- Catalog Number
- BU.580 FDA UDI
- Primary DI / UDI-DI
- 00896100002156 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00896100002156 EUDAMED
- 510(k) Number
- K140199 FDA UDI
- FDA Product Code
- IYO FDA UDI
- EMDN Code
- Z11040199 ULTRASOUND SCANNERS - OTHER EUDAMED
- GMDN Term
- Ophthalmic ultrasound imaging system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1560 FDA UDI
- Market of Registration
- Spain 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
VuPad by Sonomed, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00896100002156 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Sonomed, Inc.
- EUDAMED SRN
- US-MF-000002342
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 8146ab3e-7d78-4ab7-9de0-d949dff3687d 61 fields · synced Jun 18, 2026
- FDA UDI 3bc12bd0-eb4d-4eda-8472-e859a3ec362b 36 fields · synced May 30, 2026