Our services in the field of labeling
The labeling of medical products is far more than just a logistical step - it is a central component of traceability and regulatory compliance. At NICOLAY, we rely on precise, durable and standard-compliant labeling solutions that can be applied both manually and automatically. Our labels meet the highest requirements for adhesion, legibility and resistance to cleaning and sterilization processes.
We integrate labeling solutions seamlessly into the production process and ensure that all relevant information - from article number and batch identification to UDI data - is applied correctly and completely.
Pad printing is a proven process for permanent and precise marking of plastic parts - especially for complex geometries and small surfaces. At NICOLAY, we use state-of-the-art pad printing systems to apply logos, symbols, scales or technical information directly to the product.
Thanks to our many years of experience in the medtech sector, we know what is important: high print quality, consistent colors, biocompatible inks and documented process control. Pad printing is ideal for products that require permanent but visually discreet marking - such as sensors, connectors or housing parts.
For particularly durable, tamper-proof and sterile markings, we rely on laser marking. This non-contact process makes it possible to permanently apply text, codes or graphics to the material - without additional consumables and with maximum precision.
Laser marking is ideal for medical technology products as it is abrasion-resistant, chemical-resistant and suitable for sterilization. It is particularly suitable for marking serial numbers, UDI codes or safety-relevant information. Our systems are validated and integrated into our quality-assured processes - for maximum traceability and regulatory security.
Clear product labeling in accordance with UDI specifications is a key element of global medical device regulation. NICOLAY supports its customers in the complete and standard-compliant implementation of UDI requirements - both in accordance with the FDA standard and the European MDR.
We integrate UDI data into labels, direct markings or packaging and ensure that all relevant information is applied in a machine-readable (e.g. as a DataMatrix code) and human-readable format. Our processes are designed in such a way that the UDI data is fully traceable and documented in an audit-proof manner - an important contribution to patient safety and compliance with regulatory requirements.
The unique serial number is a central element of traceability and quality assurance in medtech. NICOLAY offers various processes for serial number marking - from labeling and pad printing to laser engraving. Depending on the product requirements and material, we select the appropriate technology to ensure permanent, legible and documented marking.
Our serial number marking is fully integrated into our ERP and quality systems. This allows us to trace when, where and under what conditions a product was manufactured at any time - a decisive advantage for audits or tracking in the field.
