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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

Allora 3 — Class I MDR by Jabbla

MD Atlas
Jabbla

EUDAMED last updated this device on May 18, 2026

Allora 3

5430000266SGDVP

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Jabbla
UDI-DI code: 54300002668576
Reference / catalog number: A3-2855

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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	Oct 3, 2022	Jun 30, 2029

Device identification

Trade name: Allora 3
UDI-DI code: 54300002668576
Basic UDI-DI: 5430000266SGDVP
Reference / catalog number: A3-2855
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 Allora 3 is a dedicated, portable, battery-operated communication device with which spoken messages can easily be generated. The Allora 3 uses text-to-speech technology. This technology ensures that any text message that is drafted on the keyboard of the Allora 3, is read out in a high-quality voice. The person listening to the drafted message can also read along on the device's partner display. The Allora 3 can be linked to a smartphone by Bluetooth. This allows you to send and receive text messages using the Allora 3. The Allora 3 has a communication support function and is intended for people with a communication impairment (unable to speak or able to speak with difficulty) for general use in everyday life and, assuming they have sufficient motor and cognitive abilities, to use the device. The Allora 3 is also equipped with an infrared module used to be able to be trained the infrared codes and transmit them to thereby control other appliances. This includes appliances for general use such as devices for audio-visual and home automation applications.
Additional information URL: https://url.jabbla.com/Allora3en
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.