VuMAX

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref BA.575Model VuMAX BA

by Sonomed, Inc.

Identity

Trade Name: VuMAX EUDAMED
VuMAX HD Ophthalmic Ultrasound System FDA UDI
Generic Name: Ophthalmic ultrasound imaging system FDA UDI
Device Name: VuMAX Ophthalmic Ultrasound EUDAMED
The VuMAX HD Ophthalmic Ultrasound System is a non-invasive, active, device for imaging ocular features for diagnostic purposes. It combines both A-scan and B-scan modes. The A-scan measures axial length (AXL), anterior chamber depth, lens thickness and vitreous length. B-scan settings include orbit, virtreous body, retina surface, and deep retina/choroid. The system includes the multi-frequency ultrasound system base unit, 22" LCD, 12 MHz B-probe, 10 MHz A-probe, keyboard and mouse, USB foot switch, and user manual. FDA UDI
Model / Reference: VuMAX BA EUDAMED
BA.575 EUDAMED
VuMAX HD A/B FDA UDI
Description: The VuMAX HD Ophthalmic Ultrasound System is a non-invasive, active, device for imaging ocular features for diagnostic purposes. It combines both A-scan and B-scan modes. The A-scan measures axial length (AXL), anterior chamber depth, lens thickness and vitreous length. B-scan settings include orbit, virtreous body, retina surface, and deep retina/choroid. The system includes the multi-frequency ultrasound system base unit, 22" LCD, 12 MHz B-probe, 10 MHz A-probe, keyboard and mouse, USB foot switch, and user manual. FDA UDI

Identifiers

Catalog Number: BA.575 FDA UDI
Primary DI / UDI-DI: 00896100002200 EUDAMEDFDA UDI
Basic UDI-DI: B-00896100002200 EUDAMED
510(k) Number: K060626 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: Italy 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

VuMAX 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-00896100002200	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 9ef82354-22a1-4193-8254-eb6d36de25b0 61 fields · synced May 31, 2026
FDA UDI a520e9b0-a580-4f22-9f34-8b9b8645676f 36 fields · synced May 30, 2026