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.
Regulatory chronology
- 02.01.2025
- TİTCK interim precautionary decisionSource: titck.gov.trA precautionary decision is an interim administrative measure: the authority pauses while it assesses a risk signal. It is not a final ruling on the product. The next line records how that assessment closed.
- 19.02.2025
- TİTCK: serious-risk indications cleared; precautionary decisions liftedSource: titck.gov.tr/duyuru/5098TİTCK's public announcement recorded that the serious-risk indications had cleared, and lifted the precautionary decisions; the product's regulatory course in Türkiye returned to its normal track. The announcement itself is the source above.
- 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. Sub-distributorships in the region are 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 precautionary decisions lifted as of 19.02.2025
- Registration
- TİTCK / ÜTS registration
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.
That authority is wider than 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.
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 current status of the TİTCK precautionary decisions?
- On 19.02.2025, serious-risk indications were cleared and the precautionary decisions were lifted.
- 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. Sub-distributorships in the region are structured under that same authority.
- Where can this record be verified?
- TİTCK announcements at titck.gov.tr (announcement 5098) for the precautionary decisions, the ÜTS registry for 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 15.07.2026. Regulatory status may change; consult official TİTCK and FDA records for the current position.