Vertigenius VG01 Head Sensor

EUDAMEDFDA UDI

Class I (EU MDR)

Ref VGHS01

by Digital Rehabilitation Limited

Identity

Trade Name: Vertigenius VG01 Head Sensor EUDAMED
Vertigenius FDA UDI
Generic Name: Biomechanical function analysis/rehabilitation software FDA UDI
Device Name: VG01 Head Sensor EUDAMED
The Vertigenius™ system is intended to assist in the delivery and tracking of a prescribed exercise regime for Vestibular and Balance Rehabilitation. The Vertigenius™ system comprises a sensor that is worn behind the ear that detects head movement, a companion smart phone app and clinician platform. Vestibular rehabilitation exercises are prescribed by clinicians for their patient using the Vertigenius™ application platform. Vertigenius™ can be used with or without the head sensor. The companion app delivers the prescribed exercise regime, provides auditory and visual cues, tracks symptoms and monitors adherence. The head sensor is worn whilst the patient is carrying out specific prescribed head movement exercises for Vestibular and Balance Rehabilitation. It is used to provide real-time feedback to the patient so that they can see if they are carrying out the prescribed exercises correctly. The sensor and connected app provide feedback via the clinician platform to the prescribing clinician on the quality of exercise performance, changes in symptoms and adherence of the patient to the prescribed exercises, enabling the clinician to remotely monitor progress. FDA UDI
Model / Reference: VGHS01 EUDAMED
VG01 FDA UDI
Description: The Vertigenius™ system is intended to assist in the delivery and tracking of a prescribed exercise regime for Vestibular and Balance Rehabilitation. The Vertigenius™ system comprises a sensor that is worn behind the ear that detects head movement, a companion smart phone app and clinician platform. Vestibular rehabilitation exercises are prescribed by clinicians for their patient using the Vertigenius™ application platform. Vertigenius™ can be used with or without the head sensor. The companion app delivers the prescribed exercise regime, provides auditory and visual cues, tracks symptoms and monitors adherence. The head sensor is worn whilst the patient is carrying out specific prescribed head movement exercises for Vestibular and Balance Rehabilitation. It is used to provide real-time feedback to the patient so that they can see if they are carrying out the prescribed exercises correctly. The sensor and connected app provide feedback via the clinician platform to the prescribing clinician on the quality of exercise performance, changes in symptoms and adherence of the patient to the prescribed exercises, enabling the clinician to remotely monitor progress. FDA UDI

Identifiers

Catalog Number: VGHS01 FDA UDI
Primary DI / UDI-DI: 05391548420029 EUDAMEDFDA UDI
Basic UDI-DI: B-05391548420029 EUDAMED
FDA Product Code: QKC FDA UDI
EMDN Code: Z12069099 VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - OTHER EUDAMED
GMDN Term: Biomechanical function analysis/rehabilitation software FDA UDI

Classification

Device Class: Class I EUDAMED
Class II FDA UDI
Regulation Number: 890.5360 FDA UDI
Market of Registration: Ireland 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Vertigenius VG01 Head Sensor by Digital Rehabilitation Limited — Class I — 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-05391548420029	Class I	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Digital Rehabilitation Limited
EUDAMED SRN: IE-MF-000048950

Sources (2)

EUDAMED 5b309188-f2f6-4c5a-896f-03cb0988d961 61 fields · synced Jun 19, 2026
FDA UDI 47ed0c8a-fddb-48a9-b180-966a414519b2 34 fields · synced May 30, 2026