VuPad

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref A.580Model VuPad A

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 Ophthalmic Ultrasound System is a portable, ultrasound biometric ruler that is a non-invasive, active device intended for imaging ocular features for diagnostic purposes. The A-Scan system allows for measuring the axial length (AXL), anterior chamber depth, and lens thickness of an eye and for calculating the associated IOL power for an implanted lens. The VuPad A-Scan is used by coupling the probe/transducer to the eye either through direct contact or by immersion method with scan mode capabilities for cataract, dense cataract, aphakic, and pseudophakic. 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 VuPad A-Scan system includes the portable A-Scan tablet, a 10 MHz A-probe, built-in probe holder, foot switch and operator manual. FDA UDI
Model / Reference: VuPad A EUDAMEDFDA UDI
A.580 EUDAMED
Description: The VuPad A Ophthalmic Ultrasound System is a portable, ultrasound biometric ruler that is a non-invasive, active device intended for imaging ocular features for diagnostic purposes. The A-Scan system allows for measuring the axial length (AXL), anterior chamber depth, and lens thickness of an eye and for calculating the associated IOL power for an implanted lens. The VuPad A-Scan is used by coupling the probe/transducer to the eye either through direct contact or by immersion method with scan mode capabilities for cataract, dense cataract, aphakic, and pseudophakic. 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 VuPad A-Scan system includes the portable A-Scan tablet, a 10 MHz A-probe, built-in probe holder, foot switch and operator manual. FDA UDI

Identifiers

Catalog Number: A.580 FDA UDI
Primary DI / UDI-DI: 00896100002170 EUDAMEDFDA UDI
Basic UDI-DI: B-00896100002170 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

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

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-00896100002170	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 2eb9571c-bd37-4ae2-abd6-384e84ea6e7b 61 fields · synced Jun 18, 2026
FDA UDI 0adfd437-1365-4d95-8a00-968f3a1036e3 36 fields · synced May 30, 2026