Organization name

EyeTech Digital Systems

SRN

US-MF-000035001

Manufacturer status

Active

*+B862EYEON10NE0/$21488*

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA / IFA support is coming.

Primary placement in XI; available across 32 countries total.

Trade name

not provided

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

*+B862EYEON10NE0/$21488*

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

++B862EYEON10NEBM

Reference / catalog number

EyeOn-10NE

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

HIBCC

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

Speech generation and communication device and software

Additional information URL

https://eyetechds.com/eyeon-go/

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Y214209ALPHABETIC AND SYMBOLIC COMMUNICATORS
• Y214299DEVICES FOR INTERPERSONAL COMUNICATION - OTHER
• Y214212VOICE GENERATORS
• Y214224AUGMENTATIVE SOFTWARE

• Class I medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.