Development, cleanroom manufacturing and marketing of heart implants and access systems for interventional cardiology.
Cormos Medical GmbH
JenaNew on Amplifa
About Cormos Medical
Cormos Medical GmbH is a medical technology company founded in 2016 and based in Jena, specializing in the development, manufacture and marketing of systems for interventional cardiology. The portfolio comprises non-active, cardiovascular implantation systems for the treatment of structural heart diseases, such as the catheter-based LAA occluder for closure of the left atrial appendage, as well as matching access systems (steerable introducer). All products are 100% manufactured in Germany, including in the modern cleanroom facility at the Jena site. The company develops Class III medical implants in accordance with Regulation EU 2017/745 (MDR) and operates its own research and development laboratory. The company is financed by private investors and works nationally and internationally with interventional cardiologists, technology partners and manufacturers. In development, among other things, are an ASD occluder and a two-part aortic valve replacement.
- Site
- Jena
- Processes
- Cleanroom manufacturing of heart implants (MDR Class III), Development and manufacture of occluders and heart valves, Manufacture of access systems (steerable introducers, sheath systems), Development, manufacture and marketing of systems for interventional cardiology, Cleanroom manufacturing, Regulatory approval of Class III medical devices (MDR), Access systems (steerable introducer)
- Materials
- Cleanroom Manufacturing, Assembly, Engineering, Plastics Processing
- Certificates
- MDR (EU 2017/745), Class III
- Founded
- 2016
- Industries
- Medical Technology, Interventional Cardiology, Structural Heart Disease
- 01
Research and Development
- 02
Cleanroom Manufacturing
- 03
Quality Management
- 04
Regulatory Approval (MDR Class III)
- 05
Marketing and Clinical Affairs
Processes and Manufacturing
Cleanroom Manufacturing
Manufacturing of heart implants under cleanroom conditions at the Jena site.
Assembly
Assembly of Class III interventional implantation systems.
Engineering
Development and manufacture of occluders and heart valves.
Plastics Processing
Manufacture of access systems such as steerable introducers and sheath systems.
Locations
Jena
DEHeadquarters with cleanroom manufacturing, research laboratory and development
- Materials
- Heart implants, access systems
- Cleanroom manufacturing system
Products and Components
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Cleanroom manufacturing of heart implants (MDR Class III)Assembly | – | – | – | – | – |
| Development and manufacture of occluders and heart valvesEngineering | – | – | – | – | – |
| Manufacture of access systems (steerable introducers, sheath systems)Plastics | – | – | – | – | – |
1 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| Cleanroom manufacturing system | – | – | – | – | Jena |
Additional services
Quality and Approval
The products meet the requirements of Regulation EU 2017/745 (MDR) for Class III medical devices. Quality management is supported by a dedicated Quality and Hygiene Management team.
| Evidence | Jena |
|---|---|
| MDR (EU 2017/745), Class III |
History
- 2016
Founding of Cormos Medical GmbH with a broad scientific basis
- 2023
Funding for innovative technologies (development, implementation and optimization of process workflows)
- 2024
Participation in CSI Focus LAA 2024