Professional Labeling of Medical Devices
Our Top Medical Devices
We offer comprehensive solutions for labeling medical devices: from durable nameplates for medical devices to specialized laboratory labels for cryogenic applications, as well as UL-compliant labels for the international market. Discover our proven products tailored to your specific needs in the medical technology sector.
Benefits of Our Labels for the Medical Technology Industry
- Compliance with DIN EN 60601-1, UL/CSA, and FDA 175.105
- Extreme temperature resistance from -196 °C to +300 °C
- Chemical- and solvent-resistant materials
- Permanent adhesion on difficult surfaces
- Complete traceability through serialization
- Over 500 specialty materials available
- 21 in-house UL approvals for rapid project implementation
- 3M-certified applicator with ISO 9001:2015 certification
Laboratory labels from robos-labels
Frequently Asked Questions About the Labeling of Medical Devices
What standards and certifications do our medical device labels meet?
Our labels for marking medical devices comply with comprehensive national and international standards:
- Labels in accordance with DIN EN 60601-1 for medical electrical equipment
- Labels with UL certification and CSA certification for the North American market
- Labels compliant with FDA 175.105 for food and medical contact
- Seawater-resistant labels certified to BS 5609 for hazardous substance labeling
Our laboratory labels also comply with the CLP Regulation, and all materials meet the REACH and RoHS directives. As an ISO 9001:2015 and ISO 14001:2015 certified company, we guarantee consistent quality and complete documentation for all regulatory requirements.
Do the labels meet the requirements of the EU Medical Device Regulation (MDR)?
Yes, our labels comply with the requirements of the EU Medical Device Regulation (MDR 2017/745), which has been in effect since May 2021 and imposes stricter requirements on the safety and transparency of medical devices.
Our MDR labeling includes all required information, such as the CE mark, manufacturer details, lot numbers, and expiration dates. The materials used ensure lasting legibility throughout the product’s entire lifespan, even under extreme conditions.
For detailed information, we offer booklet and multi-layer labels that allow for multilingual instructions for use and safety warnings in a very small space. We would be happy to provide you with personalized advice on MDR-compliant labeling for your medical devices and work with you to develop the optimal labeling solution.
What is the temperature resistance of the labels?
Our laboratory labels cover an extreme temperature range from -196 °C to +300 °C. For cryogenic applications in the laboratory environment, we offer special low-temperature labels that remain securely attached even when stored in liquid nitrogen. High-temperature labels made of polyimide are perfect for sterilization processes and autoclaving.
Nameplates for medical devices easily withstand repeated cleaning and disinfection cycles at elevated temperatures. For labeling medical device packaging, temperature-resistant materials are available that can withstand both deep-freeze storage and thermal sterilization processes. Each material is individually tailored to your specific temperature requirements.
What materials are suitable for cryogenic storage at -196 °C?
For extreme cold during cryogenic storage, we rely on highly specialized polyester and polyolefin materials with special low-temperature adhesives. These laboratory labels remain permanently legible even at -196 °C in liquid nitrogen and adhere securely to vials, tubes, and other small containers. The materials are resistant to condensation and extreme temperature fluctuations during storage and retrieval.
Our cryogenic labels can be labeled before storage or printed with variable data afterward. We’re happy to provide free material samples so you can test their suitability for your specific cryogenic application.
Can the labels be printed with barcodes or QR codes after the fact?
Yes, our labels are optimized for subsequent marking using thermal transfer printing, laser engraving, or inkjet printing. The surfaces ensure that the codes remain legible even under extreme conditions. Alternatively, we can print customized barcodes, QR codes, and serialized data onto your labels during the manufacturing process.
Are there labels for small containers such as vials and tubes?
Yes, we manufacture special vial and tube labels for small diameters and radii. These laboratory labels adhere securely to the curved surfaces of small containers and remain permanently legible even at extreme temperatures ranging from -196 °C to +300 °C. The labels can be customized with barcodes, QR codes, or variable data for unique identification. Please feel free to contact us regarding your specific application.
What solutions are available for nameplates on medical devices?
For nameplates on medical devices, we offer durable materials made of polyester, polyimide, or aluminum that are designed for long-lasting labeling of medical devices. These nameplates comply with DIN EN 60601-1 and have UL/CSA approvals. They withstand chemical cleaning agents, mechanical wear, and UV radiation for years.
