← Back to catalogue

VuPad

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref BUP.580Model VuPad B/UBM/P

by Sonomed, Inc.

Identity

Trade Name
VuPad EUDAMED
VuPad Ophthalmic Ultrasound System FDA UDI
Generic Name
Ophthalmic ultrasound imaging system FDA UDI
Device Name
VuPad Ophthalmic Ultrasound EUDAMED
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, UBM (high frequency B-scan), and 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 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 B-Scan/UBM tablet, 12 MHz B-probe, water-path probe with 35 MHz transducer, 20 MHz pachymetry probe, power supply, foot switch and user manual. FDA UDI
Model / Reference
VuPad B/UBM/P EUDAMEDFDA UDI
BUP.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, UBM (high frequency B-scan), and 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 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 B-Scan/UBM tablet, 12 MHz B-probe, water-path probe with 35 MHz transducer, 20 MHz pachymetry probe, power supply, foot switch and user manual. FDA UDI

Identifiers

Catalog Number
BUP.580 FDA UDI
Primary DI / UDI-DI
00896100002057 EUDAMEDFDA UDI
Basic UDI-DI
B-00896100002057 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 EUDAMED
Class 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Sonomed, Inc.
EUDAMED SRN
US-MF-000002342
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (2)

  • EUDAMED 1d208ca0-655f-43ec-8bd4-d0fd91aac534 61 fields · synced Jun 19, 2026
  • FDA UDI 7eda6102-8038-46aa-89b6-fc3e362e953a 36 fields · synced May 30, 2026