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VuPad

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref BA.580Model VuPad A/B

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 A/B-Scan Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biometric device intended for use in ophthalmic applications.The system includes both A-Scan and B-Scan capabilities. 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 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 A/B-scan tablet, 12 MHz B-probe, 10 MHz A-probe, built-in probe holders, foot switch and user manual. FDA UDI
Model / Reference
VuPad A/B EUDAMEDFDA UDI
BA.580 EUDAMED
Description
The VuPad A/B-Scan Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biometric device intended for use in ophthalmic applications.The system includes both A-Scan and B-Scan capabilities. 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 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 A/B-scan tablet, 12 MHz B-probe, 10 MHz A-probe, built-in probe holders, foot switch and user manual. FDA UDI

Identifiers

Catalog Number
BA.580 FDA UDI
Primary DI / UDI-DI
00896100002132 EUDAMEDFDA UDI
Basic UDI-DI
B-00896100002132 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

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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 da0594e6-fd58-4d4b-a33c-634e2e0a426e 61 fields · synced Jul 11, 2026
  • FDA UDI da7227ad-f23d-41b9-862d-c30b48ac22ae 36 fields · synced May 26, 2026