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Allurion in Türkiye: Regulatory Chronology and the Distributorship Mandate

This page is the dated public record of Allurion Technologies Inc. in Türkiye: the regulatory chronology, and the distributorship mandate under which the product is registered and represented. It is written for corporate due diligence, not for patients. Every dated line names its source.

Chronology in Türkiye

2021
Start of field continuity on the product lineSource: AlzeyField work and the relationship network on this product line date from this year; the legal entity follows later. This line records corporate continuity.
2024
Incorporation of Alzey Danışmanlık ve Ticaret Ltd. Şti.Source: AlzeyThe legal entity was incorporated in 2024; as of today the TİTCK licence, the ÜTS registration and import run in its name. This line records the incorporation; it does not show the licence or registration dates.
23.02.2026
FDA PMA full approval — Class III (not 510(k))Source: FDAPMA is the FDA's premarket approval route for Class III devices: the manufacturer defends the application on its own evidence file rather than clearing the device by equivalence to a predicate, as a 510(k) does. This line records the process; it makes no claim about clinical outcomes.
Ongoing
Alzey Danışmanlık ve Ticaret Ltd. Şti. = Master Distributor for Allurion Swallowable Gastric Balloon and Allurion VCS across Türkiye and the CISSource: AlzeyMaster distributorship here means one authority: the regulatory obligations and the commercial representation of these two product lines across Türkiye and the CIS sit under it. The regional distribution network is structured under that same authority.

Regulatory status

FDA
PMA Class III full approval· 23.02.2026
CE
CE 0123 (TÜV SÜD) — Article 120 transition regime
Türkiye
TİTCK licensed · ÜTS registered

Regulatory status may change; consult official TİTCK and FDA records for the current position.

Licence holding and the distributorship mandate

Alzey Danışmanlık ve Ticaret Ltd. Şti. is the Master Distributor for the Allurion Swallowable Gastric Balloon and Allurion Virtual Care Suite (VCS) lines across Türkiye and the CIS. The regulatory compliance and commercial representation of these two lines run under that authority.

The authority is not limited to commercial distribution: TİTCK and ÜTS registrations, import, supply to authorised centres and the coordination of field reports back to the manufacturer all sit under one agreement; for the manufacturer, the practical consequence is a single accountable counterparty in the region.

What the mandate covers

  1. TİTCK licence
  2. ÜTS registration
  3. Import
  4. Supply to authorised centres
  5. Commercial representation
  6. Coordination of field reports

What this mandate means for the manufacturer

Being the registration holder and importer in Türkiye also keeps the responsibility with us: the licence file, import, supply to authorised centres and the return of field reports to the manufacturer are our obligation. The distribution network in Kazakhstan, Uzbekistan, Georgia and Azerbaijan runs under the same authority; the current position is set out in the operating regions table on the home page.

The Components of the Allurion Program

Used in the context of obesity management, the Allurion Program comprises a swallowable gastric balloon and the follow-up components that accompany it. Programme information for physicians and clinics sits on a separate surface: allurion.alzeypartners.co. No clinical effect or weight outcome is shared on this page.

The Allurion Program has four components: the Smart Capsule, the Smart Scale, the mobile app and six months of nutritional follow-up. The diagram below shows how the four relate structurally; it makes no claim about clinical use of the product.

  1. Smart CapsuleThe balloon in capsule form, with its placement catheter.
  2. Smart ScaleThe programme's connected scale; part of the VCS line.
  3. Mobile appThe patient-side app; part of the VCS line.
  4. Six-month nutritional follow-upThe programme's follow-up component; its content sits in the manufacturer's official programme definition.
Allurion Program components on a neutral ground: mobile app screen, Smart Scale, Smart Capsule with placement catheter, and the balloon.
Allurion Program components — the manufacturer's product record frame. The image belongs to Allurion Technologies Inc. and is used solely as a record of the represented line.

How the programme works

The chain below follows the order described in the manufacturer's instructions for use. Use of the programme is defined together with a supervised nutrition programme, and the physician placing the device is required to be certified or trained on the system. What follows describes how the device is used; it carries no outcome, effect or eligibility assessment.

Programme information for physicians and clinics sits on a separate surface: allurion.alzeypartners.co. No clinical effect or weight outcome is shared on this page.

Source: the manufacturer's instructions for use
  1. SwallowingThe balloon is supplied inside a capsule and is swallowed to reach the stomach. During swallowing the end of the delivery catheter stays outside the mouth, which is what makes the next step possible.
  2. Position confirmationThat the capsule has reached the stomach is confirmed by x-ray and/or fluoroscopy. The instructions require that no filling take place until that confirmation is complete.
  3. Filling and catheter removalOnce the position is confirmed, the balloon is filled with fluid using its own filler kit. After filling, the catheter is drawn back and detached from the device.Approximately 16 weeks
  4. Automatic deflationAt the end of the period, the device is designed to open and drain on its own.
  5. Natural passageThe emptied balloon is designed to transit the digestive tract and leave the body without further intervention.

The filled balloon is designed to remain in the stomach for approximately 16 weeks; this may vary from patient to patient. This description is taken in full from the manufacturer's instructions for use; the decision to place and the patient's suitability rest with the physician.

What the represented lines are

Master Distributorship for Türkiye and the CIS · one authority

Allurion Swallowable Gastric Balloon

Line
Balloon line
Definition
An intragastric balloon line placed by swallowing a capsule. This page makes no claim about clinical use; product information sits in the manufacturer's official material, and the decision to treat sits with the physician.
Component
Smart Capsule — the balloon in capsule form, with its placement catheter.

Allurion VCS

Line
Virtual Care Suite — the digital follow-up layer
Definition
The programme's digital follow-up layer: the patient-side mobile app, the connected scale and the clinic-side follow-up panel. Our distribution mandate covers both lines together, and the registration and compliance obligations run under the same roof for both.
Components
Mobile app · connected scale · clinic-side follow-up panel.

The route to becoming an authorised centre

In Türkiye the product moves only to authorised centres; a centre's authorisation begins with its physicians completing the Allurion Academy certification process. Supply, after-sales and vigilance reporting then run under the same authority. The sequence below shows the corporate steps of centre authorisation; clinical-use information is outside the scope of this page.

  1. Academy certificationThe centre's physicians go through the manufacturer's certification process.
  2. Authorised centreCertification is the precondition for a centre's authorisation.
  3. Supply and after-salesThe product is supplied to the authorised centre; after-sales runs on the same line.
  4. VigilanceA report from the field is logged and coordinated with the manufacturer.

How the operation is set up in Türkiye

Import runs in our own name and buffer stock is held in our own warehouse; authorised centres are supplied from it. Physician training proceeds by certification, with content from the manufacturer's official programme. A report from the field is logged, filed with the competent authority where required and closed in coordination with the manufacturer; that responsibility continues after the sale.

The ten steps of the chain are on the Medical page; the vigilance and compliance set-up is on Quality & Compliance.

Frequently asked questions

Who holds the distributorship mandate for Allurion products in Türkiye?
Alzey Danışmanlık ve Ticaret Ltd. Şti. is the Master Distributor for the Allurion Swallowable Gastric Balloon and Allurion VCS lines across Türkiye and the CIS.
What is the CE status of the product?
The product carries CE 0123 (TÜV SÜD) under the Article 120 transition regime. Regulatory status can change; the official records are the reference.
What does the master distributorship cover?
TİTCK and ÜTS registrations, import, supply to authorised centres and commercial representation, under one authority. The regional distribution network is structured under that same authority.
Where can this record be verified?
The TİTCK and ÜTS registries for the Turkish registration, and the FDA's public records for the US approval. Each line in the chronology names its source.

This page was last reviewed on 20.08.2026. Regulatory status may change; consult official TİTCK and FDA records for the current position.

Corporate contact