VuPad

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref B.580Model VuPad 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 B-Scan Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biometric device intended for use in ophthalmic applications by imaging the internal structures of the eye.The VuPad B-Scan is a multi-purpose, computer-based,ultrasonic diagnostic system that 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 tablet, 12 MHz B-probe, built-in probe holder, foot switch and user manual. FDA UDI
Model / Reference: VuPad B EUDAMEDFDA UDI
B.580 EUDAMED
Description: The VuPad B-Scan Ophthalmic Ultrasound System is a non-invasive, active, diagnostic and biometric device intended for use in ophthalmic applications by imaging the internal structures of the eye.The VuPad B-Scan is a multi-purpose, computer-based,ultrasonic diagnostic system that 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 tablet, 12 MHz B-probe, built-in probe holder, foot switch and user manual. FDA UDI

Identifiers

Catalog Number: B.580 FDA UDI
Primary DI / UDI-DI: 00896100002125 EUDAMEDFDA UDI
Basic UDI-DI: B-00896100002125 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-00896100002125	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 4e6bfdd2-a03f-4277-856f-60dd92fae2c5 61 fields · synced Jun 17, 2026
FDA UDI 4c725a67-c979-4eac-9c3a-a9bf8d01d6b9 36 fields · synced May 30, 2026