How to read a medical device label: REF, LOT, UDI and ÜTS
The small boxes on a carton make purchasing easier. What REF, LOT, expiry, the sterile symbol, CE and UDI tell you, and what to check in Türkiye’s ÜTS.
When a carton of gloves or a box of syringes arrives, the label is the first thing to check. Medical device label symbols are defined by ISO 15223-1, so the same box means the same thing in any language. Here are the fields that warehouse, pharmacy and purchasing teams mix up most often.
REF and LOT
REF is the manufacturer’s catalogue number and stays the same across production runs. Using it when you order or request a quote prevents mix-ups between similarly named products. LOT is the batch number. In a recall the manufacturer announces lot numbers, and you find the affected cartons by this number.
Expiry and manufacturing date
The hourglass shows the expiry date, the factory symbol the date of manufacture. For sterile products the expiry date is the end of guaranteed sterility: once passed, the product is not used even if the pack looks intact. That is why stores should follow FEFO (first expiry, first out) rather than plain FIFO.
The STERILE box
The letters next to “STERILE” give the method: EO ethylene oxide, R irradiation, S steam. A crossed-out “2” means single use; the device must not be resterilised.
The CE mark and its four digits
The four-digit number next to the CE mark identifies the notified body that assessed the product. Class I devices (non-sterile, no measuring function) do not carry it; classes Is, IIa, IIb and III do. You can look the number up in the European Commission’s NANDO database.
UDI and ÜTS
The UDI (Unique Device Identifier) is printed as a barcode or data matrix. Its UDI-DI identifies the product and the UDI-PI the lot, serial and dates. In Türkiye medical devices are registered in the Product Tracking System (ÜTS); healthcare facilities report the devices they use, so the product on the invoice must match its ÜTS record exactly.
Purchasing checklist
- Is the REF number on the quote and the invoice?
- Do the lot and expiry on the carton match the delivery note?
- Does a class Is or higher device show a notified body number next to the CE mark?
- Is the product’s ÜTS record active?
- Are the declaration of conformity and instructions for use (IFU) on file?
