UTS Registration in Turkey for Medical Devices
October 1, 2026
Medical Device Sales Centre Authorisation in Turkey
October 1, 2026
UDI (Unique Device Identification) is the system used to identify medical devices unambiguously and to trace them from the manufacturer to the end user. It makes recalls faster, supports market surveillance and is a legal requirement under the EU Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR). Turkey applies aligned rules, and the UDI-DI of each device is entered in ÜTS (Ürün Takip Sistemi, the Turkish Product Tracking System) when the product is registered. A foreign manufacturer who sells in Turkey therefore needs its UDI data in order before the importer can register the product.
For UDI assignment and registration, apply to CE Danışmanı (CE Consultant); we manage the whole process for you.
The three identifiers
| Identifier | What it identifies | Where it appears |
|---|---|---|
| Basic UDI-DI | A device family or model series with the same basic characteristics | In the documentation and the database, as the key that groups the individual devices. |
| UDI-DI (device identifier) | One specific model in one specific version and packaging configuration | On the label and packaging, and in the database |
| UDI-PI (production identifier) | The production unit: lot or batch number, serial number, manufacturing date, expiry date and, where relevant, software version | On the label and packaging |
Several devices of the same family each carry their own UDI-DI and are grouped under one Basic UDI-DI. The Basic UDI-DI is a concept of the EU system.
Who issues UDI codes?
Commission Implementing Decision (EU) 2019/939 of 6 June 2019 designated four issuing entities:
- GS1: uses the GTIN (Global Trade Item Number). In the GS1 system the UDI-DI is the GTIN of the device.
- HIBCC (Health Industry Business Communications Council): uses the HIBC standard.
- ICCBBA: manages ISBT 128, used for blood, cells, tissues and organs.
- IFA GmbH: assigns the PZN, used in the pharmacy sector in Germany.
Which entity to choose depends on the product group and on the barcode infrastructure you already use.
Rules for the UDI-DI
- Each model or version has one UDI-DI.
- The UDI-DI stays fixed for that model. When the model or version changes, a new UDI-DI is assigned.
- Each packaging level has its own UDI-DI.
Labelling
The UDI appears on the label or packaging of the device in two forms:
- Machine-readable: a barcode or, for example, an RFID tag
- Human-readable: the same information in plain characters
The lot number in the UDI-PI
The lot or batch number identifies one production run. It links the product to the conditions and dates of its manufacture and to the quality control results for that run. If a problem is found, the recall can be limited to the affected lot, without withdrawing every unit of the product from the market.
Databases
| Market | Database | What is entered |
|---|---|---|
| European Union | EUDAMED (European Database on Medical Devices) | The actor is registered first and receives a Single Registration Number (SRN). Devices are then registered with their Basic UDI-DI and UDI-DI, class, intended purpose and other data, which are kept up to date. |
| Turkey | ÜTS | The UDI-DI is entered at product level during product registration. |
| United States | GUDID (Global Unique Device Identification Database) of the FDA | The device identifier and the related device data. See FDA registration. |
UDI and selling in Turkey
For the Turkish market, three steps follow one another:
- The company that sells the device obtains its medical device sales centre authorisation.
- The company is registered in ÜTS.
- Each product is registered in ÜTS with its documents and its UDI-DI.
The code on the label and the code entered in ÜTS must be the same.
What UDI gives you
- Traceability from production to the end user
- Safety: fast action in the event of a device fault or a recall
- Transparency for authorities and users
- Compliance with MDR and IVDR and with the Turkish rules aligned with them
How CE Danışmanı helps
- Structuring device families: Basic UDI-DI, UDI-DI and packaging levels
- Choosing the issuing entity and obtaining the codes
- Checking labels and the consistency of UDI data with the technical file and the Declaration of Conformity
- Entering UDI data in ÜTS and supporting EUDAMED registration
