Laser marking puts permanent information on an instrument, such as the brand, item code and a scannable code. UDI (Unique Device Identification) is a system required by regulators in the EU, the USA and other markets to identify medical devices. Together they make instruments traceable.
Types of marking
- Etched or laser text: Brand, item code, “stainless” and CE mark.
- Data Matrix code: A small square code that a scanner reads. It can hold the UDI or the hospital’s own tracking number.
Why hospitals want marked instruments
- Track instruments through use, cleaning and sterilisation
- Rebuild sets correctly after reprocessing
- Find instruments quickly when a recall happens
- Count usage and plan replacements
What UDI is
A UDI has two parts:
- Device identifier (UDI-DI): Identifies the product model.
- Production identifier (UDI-PI): Identifies the batch or lot, and sometimes the serial number.
Under the EU MDR and US FDA rules, UDI must appear on labels and, for many reusable devices, directly on the device. Requirements depend on the device class and timeline, so check your market’s rules.
What to ask suppliers
- Can you laser mark my brand and item codes?
- Can you add a Data Matrix code?
- Can you assign and manage UDIs for my products?
- Does the marking survive many sterilisation cycles?
Laser marking at Tata Surgical
We laser mark instruments with your brand and codes. See samples at Hall 10, Stand C32.
Looking for instruments like these?
Browse our catalogue or send us your drawing. We reply with prices, lead time and shipping terms.
