What is UDI (Unique Device Identification)?
UDI is a standardized numeric or alphanumeric coding system applied to medical devices, that accompanies the device throughout its entire life cycle – from manufacture and distribution to clinical use and patient tracking. The framework and compliance standards for UDI are globally harmonized by international bodies such as the International Medical Device Regulators Forum (IMDRF) and enforced by major health authorities, including the U.S. Food and Drug Administration (FDA) and the European Commission under the Medical Device Regulation (MDR), with codes issued through accredited organizations like GS1 and HIBCC.
UDI can be applied as a 1D or 2D machine readable code and a human readable code. Considering that many MD are rather small, a 2D machine readable code in the form of a datamatrix is a convenient choice since it can be miniaturized to 1mm and below.
Key Requirements for Device Markings:
Space constraints:
Due to the extremely limited surface area available on small instruments and implants,
the marking must be exceptionally small and highly detailed.
Tactile imperceptibility:
The markings must be completely smooth and imperceptible to the touch.
Long-term legibility:
They must remain perfectly legible over time.
Sterilization resistance:
In the case of reusable equipment, they must
withstand repeated cycles of decontamination and autoclave sterilization.
Ultra-short pulse lasers – specifically picosecond lasers – represent the most suitable technology to meet these demanding requirements.
Picosecond technology delivers exceptional results with superior black-marking contrast, ensuring high legibility even on challenging metallic surfaces.
This advanced laser technology enables the creation and reliable scanning of extremely small, high-density QR codes on micro-devices and surgical instruments without compromising the material integrity.
Laser marking is highly automated thanks to the CVS (Coaxial Vision System) and Pattern matching software.
The optimized picosecond process also enabled SISMA to produce extremely small Data Matrix codes, providing a reliable solution for components with highly restricted marking areas.
Results and Benefits
SISMA laser marking systems are the most effective solutions
for UDI marking delivering:
• High-contrast, durable markings
• Excellent definition on very small components
• Reduced processing times
• Repeatable production results
• Precise marking of Data Matrix codes
• Automated management of identification data
SISMA machines equipped with picosecond lasers
that can adapt to different UDI marking needs
Contact SISMA to discuss a laser-marking test
for your application
Il numero seriale o il numero Matricola
si trovano in una targhetta applicata sulla
macchina. Inizia con OR per le macchine a catena e per L o LS per le macchine laser.
Di seguito alcuni esempi:
