FactoryCode

The One Smart Solution for your UDI compliance with ease!

Your Benefits

Easy UDI-Check as retrofit

Produce safer and more traceable products

  • Provide a high level of protection for the health of patients
  • Improve the safety and performance of your medical devices
  • Create traceability on your entire supply chain.

Fulfil MDR (EU)
2017/745 regulation

  • Test according ISO/IEC 15416 and 15415
  • In-Line Quality check
  • IQ/OQ support

Save time & money

  • Complete solution
  • Plug & Play installation
  • Fits to all production machines and printers
  • Integration: EUDAMED, ERP, CAQ

Get additional insights

  • Analyse quality and Production data
  • Detect scrap early
  • Avoid recalls
  • Trace your products and production orders
Book a Demo

Solution Overview

Check Code Quality
Connect Data
Create Insights
Customer References:
Book a Demo

CodeSens automatically verifies the quality of printed UDI-Codes. This is an extremely important
process in production, because someone's health depends on the quality of the UDI code of the
medical device!

User authorisation via Key Cards

Connect to printer or direct labelling device (e.g. Laser)

Notification of operators via traffic light or display

In-Line Quality check after ISO 15416 & ISO 15415

Compare UDI code content and check print quality

Automatically eject products with bad label or UDI-Code

IQ / OQ templates and training material

Connect to additional data sources like SPS and sensors

Solution Video

Take a closer look at our FactoryCode product!

Book a Demo

CodeCore is an innovative cloud-IoT-platform that enables connectivity to all needed data sources and what is more important, CodeCore keeps all data safe. Via our partners we also provide EUDAMED database management

Device Management

Secure data management in the cloud

Easy integration with existing systems like ERP via API and more

No internal maintenance costs due to fully managed platform

Live analysis over data from
different sources

Highest safety standard due to German servers and private key infrastructure enabled (SSL secured)

CodeVisual creates and visualizes additional insights for UDI-Data and Quality-Management. Quality is an essential part of FactoryCode, it is our standard. To assist you in gaining data insights, the data values will be displayed in our FactoryVisual. These visual insights and alerts support data-driven decisions.

What our Customers Say

Customer References

Problem

New regulation requires unique identify number and its
UDI-Quality Check for all medical products

Solution

Continuous In-Line quality check via FactorySens and Sensor automated sorting of bad parts and data analysis.

Customer benefits

Quality increase, traceability and fulfilment of regulation.

Customer Reference Article Medizin und Technik 5/22

Start now and don’t risk to pay penalties

Atrify & FactoryPuls partnership

We would like to introduce you to our partner for an easy and compliant EUDAMED registration – atrify

EUDAMED is a web-based database that maintains all medical device regulatory information. The primary reason for the creation of EUDAMED is to enhance information sharing between the European Commission and competent agencies in EU member states.

atrify is the leading provider of product content solutions that enables more than 20,000 users in over 50 countries to share accurate and reliable content with UDI Regulatory bodies (such as EUDAMED or GUDID) as well as their commercial trading partners and end-users such as doctors, nurses or patients.

Using our FactoryCode, be sure that you can register your UDIs quickly, easily and compliantly in EUDAMED thanks the UDI Solution from our partner – atrify.

Through close cooperation with the European Commission, the EU Member States and the Trade associations, atrify was able to actively accompany the introduction of EUDAMED