Development and manufacturing of fully automated analyzer systems, software and polymer-based consumables for OEM partners in diagnostics and life sciences.
STRATEC SE
Birkenfeld (DE) · Beringen (CH) · Anif (AT) · Cluj-Napoca (RO) · Budapest (HU) · Ronkonkoma, NY (US) · Medley, FL (US) · New Delhi (IN) · Taicang / Shanghai (CN)New on Amplifa
About STRATEC
Founded in 1979 in Birkenfeld, STRATEC SE operates as an OEM partner for in-vitro diagnostics and life science companies. The company develops and manufactures fully automated analyzer systems, software and IoT solutions as well as polymer-based consumables, covering nearly the entire value chain from specification through engineering and production to quality assurance. Manufacturing includes the assembly of complex analyzer instruments, injection molding production of custom plastic parts including secondary processes, and the development and production of reagents for hematology and clinical chemistry analyzers. Its customers are diagnostics and biotechnology companies operating worldwide, to whom STRATEC also provides regulatory support and manufacturing transfer. The group is organized as a Societas Europaea and is publicly listed (SDAX) with locations in Germany, Switzerland, Austria, Romania, Hungary, the USA, India and China.
- Site
- Birkenfeld
- Processes
- Development and series production of fully automated analyzer systems (OEM), Assembly/manufacturing of automated analyzer instruments (in-vitro diagnostics and life sciences), Development and production of software, digital automation and IoT solutions, Injection molding of custom plastic parts incl. assembly and secondary processes, Tooling procurement and maintenance of injection molds according to customer specification, Design and manufacturing of hematology and clinical chemistry analyzers and reagents, Quality testing and inspection of products across the entire life cycle (QA), Repair of analyzer instruments
- Materials
- Polymer (polymer-based consumables), Plastic (custom injection molded plastic parts), Injection molding of custom plastic parts
- Certificates
- ISO 9001:2015, ISO 13485:2016, ISO 13485 MDSAP, ISO 13485 (STRATEC Switzerland AG), ISO 9001 (Diatron MI Zrt.), ISO 13485 (Diatron MI Zrt.), ISO 13485 (STRATEC Consumables GmbH), ISO 9001 (Natech Plastics, Inc.), ISO 9001, ISO 13485, MDSAP
- Founded
- 1979
- Industries
- In-vitro diagnostics (IVD), Life Sciences, Biotechnology, Medical technology
- 01
Engineering/Design (OEM development)
- 02
Software and IoT development
- 03
Tooling procurement for injection molds
- 04
Injection molding and secondary processes (consumables)
- 05
Assembly/manufacturing of analyzer instruments
- 06
Regulatory support (approval)
- 07
Quality assurance and inspection
Materials & Processes
Polymer (polymer-based consumables)
Plastic materials for smart, complexly processed consumables in diagnostics.
Injection molding of custom plastic parts
Injection molding including assembly and secondary processes according to customer specification (Natech Plastics).
Locations
Birkenfeld
DEHeadquarters – Instrumentation (development, production, sales)
Beringen
CHProduction (STRATEC Switzerland AG, formerly Robion AG); manufacturing and repair of analyzer instruments
Anif
AT- Materials
- Polymer
Cluj-Napoca
ROEngineering center (STRATEC Biomedical S.R.L.)
Budapest
HUDiatron MI Zrt. – development and manufacturing of hematology and clinical chemistry analyzers and reagents
Ronkonkoma, NY
USNatech Plastics, Inc. – injection-molded consumables, custom plastic parts incl. assembly and secondary processes
- Materials
- Plastic
- Injection molding machines
Taicang / Shanghai
CNProduction sites China (STRATEC Biomedical Taicang 2013, Shanghai 2024)
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Development and series production of fully automated analyzer systems (OEM)Engineering | – | – | – | – | – |
| Assembly/manufacturing of automated analyzer instruments (in-vitro diagnostics and life sciences)Assembly | – | – | – | – | – |
| Development and production of software, digital automation and IoT solutionsEngineering | – | – | – | – | – |
| Plastics | – | – | – | – | Polymer (plastic) |
| Injection molding of custom plastic parts incl. assembly and secondary processesPlastics | – | – | – | – | Plastic |
| Tooling procurement and maintenance of injection molds according to customer specificationPlastics | – | – | – | – | Plastic |
| Design and manufacturing of hematology and clinical chemistry analyzers and reagentsEngineering | – | – | – | – | – |
| Quality testing and inspection of products across the entire life cycle (QA)Testing | – | – | – | – | – |
| Repair of analyzer instrumentsAssembly | – | – | – | – | – |
Additional services
Quality Management
The STRATEC Group maintains a group-wide quality management system with QA inspections across the entire product life cycle, risk management (FMEA), supplier quality management and continuous improvement based on Lean and Six Sigma. Certifications include ISO 9001, ISO 13485 and MDSAP for several group locations.
| Evidence | Birkenfeld | Beringen | Budapest | Anif | Ronkonkoma, NY |
|---|---|---|---|---|---|
| ISO 9001 | |||||
| ISO 13485 | |||||
| MDSAP |
History
- 1979
Founded in Birkenfeld; first product: level control system for industrial applications
- 1987
Development of the first medical systems
- 1989
World's first fully automated luminescence analyzer; entry into in-vitro diagnostics
- 1993
Introduction of systems for bio-/chemiluminescence and coagulation
- 1996
Start of development of an automation platform for microplate applications
- 1998
Stock exchange listing
- 2005
Foundation of Robion AG (today STRATEC Switzerland AG) in Beringen
- 2008
Foundation of STRATEC Biomedical Systems S.R.L. in Romania
- 2013
Foundation of STRATEC Biomedical (Taicang), China
- 2016
Acquisition of Sony DADC BioSciences (today STRATEC Consumables, Anif) and Diatron MI PLC, Budapest
- 2018
Conversion into a European stock corporation (STRATEC SE)
- 2020
Admission to the SDAX
- 2023
Acquisition of Natech Plastics Inc. (USA); foundation of Diatron MI APAC Private Ltd., New Delhi
- 2024
Foundation of STRATEC Biomedical (Shanghai), China