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 A-Scan, B-Scan, UBM (high frequency B-scan),a nd pachymetry. 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 A-Scan mode measures axial length (AXL), anterior chamber depth, and lens thickness and aids in the calculation of associated IOL power for implanted lenses. The pachymeter measures the central corneal thickness 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 tablet, 12 MHz B-probe, 10 MHz A-probe, water-path probe with 35 MHz transducer, 20 MHz pachymetry probe,power supply, foot switch and user manual. FDA UDI
- Model / Reference
- VuPad A/B/UBM/P EUDAMEDFDA UDIBUAP.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 A-Scan, B-Scan, UBM (high frequency B-scan),a nd pachymetry. 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 A-Scan mode measures axial length (AXL), anterior chamber depth, and lens thickness and aids in the calculation of associated IOL power for implanted lenses. The pachymeter measures the central corneal thickness 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 tablet, 12 MHz B-probe, 10 MHz A-probe, water-path probe with 35 MHz transducer, 20 MHz pachymetry probe,power supply, foot switch and user manual. FDA UDI
Identifiers
- Catalog Number
- BUAP.580 FDA UDI
- Primary DI / UDI-DI
- 00896100002064 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00896100002064 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-00896100002064 | 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 955d27cd-2166-4c13-ba29-ae8c0408f655 61 fields · synced Jul 15, 2026
- FDA UDI ae5f4349-67ca-4e4e-96df-9280fd6386b6 36 fields · synced May 30, 2026