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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

Tellus i6 — Class I MDR by Jabbla

MD Atlas
Jabbla

EUDAMED last updated this device on May 18, 2026

Tellus i6

5430000266SGDVP

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Jabbla
UDI-DI code: 54300002668712
Reference / catalog number: T6-2633

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Manufacturer information

Organization name: Jabbla
SRN: BE-MF-000049893
Manufacturer status: Active

Market distribution

Primary placement in Belgium; available across 1 country total.

Country	On market since	Until
BelgiumPrimary placement	Feb 1, 2021	Jul 1, 2027

Device identification

Trade name: Tellus i6
UDI-DI code: 54300002668712
Basic UDI-DI: 5430000266SGDVP
Reference / catalog number: T6-2633
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The Tellus i6 is a dedicated, portable, battery-operated Speech Generating Device (SGD) specifically designed for individuals who rely on augmentative and alternative communication (AAC), including but not limited to individuals with amyotrophic lateral sclerosis (ALS), cerebral palsy, aphasia, and non-verbal autism. The device enables users to create messages using symbol-based or text-based page sets, which are converted into audible speech through integrated text-to-speech technology. Internal amplified speakers (4) ensures that generated messages are output clearly and at sufficient volume. Easily accessible physical volume controls allow the user to adjust output levels as needed. Message selection is performed via direct touch using a finger or capacitive stylus on the touch-screen. The Tellus i6 also supports alternative access methods, including one and two switch scanning. For users who require hands-free access, the integrated front-facing camera can support head tracking as an alternative access method. The Tellus i6 also supports eye tracking based on the integrated Tobii eye tracking technology.
Additional information URL: https://www.jabblasoft.com/files/helpfiles/tellus6_en_webhelp/index.html
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y214212VOICE GENERATORS

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.