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OSYPKA AG
Earl-H.-Wood-Str. 1,
79618
Rheinfelden
Germany
Germany
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Our range of products
Product categories
- 01 Manufacturing of components
- 01.02 Plastics processing
- 01.02.01 Injection molding
Injection molding
- 01 Manufacturing of components
- 01.02 Plastics processing
- 01.02.02 Extrusion
Extrusion
- 01 Manufacturing of components
- 01.03 Toolmaking, mold making
Toolmaking, mold making
- 01 Manufacturing of components
- 01.06 Laser processing
- 01.06.01 Laser cutting
Laser cutting
- 01 Manufacturing of components
- 01.06 Laser processing
- 01.06.02 Laser welding
Laser welding
- 01 Manufacturing of components
- 01.06 Laser processing
- 01.06.03 Laser marking
Laser marking
- 02 Manufacturing of finished products
- 02.02 Catheters
Catheters
- 02 Manufacturing of finished products
- 02.08 Implants (active)
- 02.08.01 Cardiac pacemakers
Cardiac pacemakers
- 02 Manufacturing of finished products
- 02.08 Implants (active)
- 02.08.02 Defibrillators
Defibrillators
- 02 Manufacturing of finished products
- 02.08 Implants (active)
- 02.08.03 Cochlea implants
Cochlea implants
- 02 Manufacturing of finished products
- 02.08 Implants (active)
- 02.08.04 Neuro-stimulators
Neuro-stimulators
- 03 Services
- 03.04 Design and development
- 03.04.01 Product design, product development
Product design, product development
- 03 Services
- 03.05 Assembly
Assembly
- Design and Development Services - Industrial Partner
- Active implants for Cardiology, neurology, Orthopaedics, ENT, and others
- Design, development and manufacturing of Catheter-based devices
- Final assembly, cleaning, packaging and contract sterilization
- Contract manufacturer of high precision medical components
- 03 Services
- 03.06 Contract packaging
Contract packaging
- Design and Development Services - Industrial Partner
- Active implants for Cardiology, neurology, Orthopaedics, ENT, and others
- Design, development and manufacturing of Catheter-based devices
- Final assembly, cleaning, packaging and contract sterilization
- Contract manufacturer of high precision medical components
- Regulatory affairs and clinical evaluation support
- 03 Services
- 03.08 Sterilization
Sterilization
- 06 Electrical components, electronical components
- 06.02 Electromechanical components
- 06.02.01 Cables
Cables
- Design and Development Services - Industrial Partner
- Active implants for Cardiology, neurology, Orthopaedics, ENT, and others
- Design, development and manufacturing of Catheter-based devices
- Final assembly, cleaning, packaging and contract sterilization
- Regulatory affairs and clinical evaluation support
- Worldwide distribution
- 06 Electrical components, electronical components
- 06.02 Electromechanical components
- 06.02.03 Enclosures
Enclosures
Our products
Product category: Product design, product development, Assembly, Contract packaging, Catheters, Cardiac pacemakers, Defibrillators, Cochlea implants, Neuro-stimulators, Cables, Enclosures
Design and Development Services - Industrial Partner
- The perfect partner to transfer your idea first into prototypes to prove full functionality and operating capability and then transfer your design into manufactural medical devices and components
- OSYPKA’s dedicated team provides design and development services, including; process development, process validations, design verifications, and other services, depending on your needs and requests
Product category: Cardiac pacemakers, Defibrillators, Cochlea implants, Neuro-stimulators, Cables, Enclosures, Injection molding, Toolmaking, mold making, Laser cutting, Laser welding, Laser marking, Product design, product development, Assembly, Contract packaging, Sterilization
Active implants for Cardiology, neurology, Orthopaedics, ENT, and others
OSYPKA is your high-tech partner for the realization of your medical product
- Electrode extensions
- Implantable power drivelines
- Inline adapters
- Implantable high-voltage connectors
- Hermetic implant encapsulation
- Polymer implant encapsulation
Product category: Injection molding, Extrusion, Catheters, Product design, product development, Assembly, Contract packaging, Sterilization, Cables, Toolmaking, mold making
Design, development and manufacturing of Catheter-based devices
- High precision multilumen catheters
- Multi-contact catheters
- Cooled tip catheters
- Sensor embedded catheter tips
- Digital data transmission
- OEM Catheters - Check OSYPKA products
- Ablation Catheters (irrigated/non-irrigated)
- Diagnostic Catheters (steerable/fixed curve)
- RF-Generator
- Valvuloplasty Balloon Catheters
- Retrieval Catheters
- Lead ExtractionSpecial Pediatric Products
Product category: Assembly, Contract packaging, Sterilization, Catheters, Cardiac pacemakers, Defibrillators, Cochlea implants, Neuro-stimulators, Cables, Enclosures
Final assembly, cleaning, packaging and contract sterilization
- Cleaning and packaging development and validation services
- Final assembly, cleaning and packaging of products in and out of cleanroom
- Contract sterilization
Product category: Injection molding, Extrusion, Toolmaking, mold making, Laser welding, Laser marking, Assembly, Contract packaging, Laser cutting
Contract manufacturer of high precision medical components
If you are looking for a manufacturing company that provides you with high-volume industrial production of your final medical device, sub-assemblies, or components, then Osypka is your single-source partner; you save costs and speed time to market.
High volume industrial production
High volume industrial production
- Final medical product
- Medical Sub-assemblies
- Medical Components
Product category: Catheters, Cardiac pacemakers, Defibrillators, Cochlea implants, Neuro-stimulators, Product design, product development, Contract packaging, Sterilization, Cables, Enclosures
Regulatory affairs and clinical evaluation support
Osypka provides support to its OEM customers in creating technical documentation to get CE and/or FDA approval for medical devices class I – III and AIMDs.
We are ISO 13485:2016 certified and FDA registered and successfully audited by the FDA as a contract sterilizer.
Furthermore,we have a GMP certificate by ANVISA (Brazil), compliant and registered for Japan (JPAL/PMDA) and our QMS is certified for Belarus and Ukraine.
We are ISO 13485:2016 certified and FDA registered and successfully audited by the FDA as a contract sterilizer.
Furthermore,we have a GMP certificate by ANVISA (Brazil), compliant and registered for Japan (JPAL/PMDA) and our QMS is certified for Belarus and Ukraine.
About us
Company details
OSYPKA is an international company located in three countries; Headquarters in Rheinfelden, Germany near Basel-Switzerland, OSYPKA Medtec in Longmont, Colorado – USA and OSYPKA s.r.o. in Odry – Czech Republic.
We are proud of our high-quality manufacturing and worldwide marketing of medical devices in the field of cardiology with a product portfolio for electrophysiology, interventional cardiology, and cardiac surgery.
We use our in-house capabilities and services to support our medical device industry partners in the field of cardiology, neurology, orthopedics, and many others.
Our high level of vertical integration provides full control over the design and development of tools, production of components, and assembly of medical products in or out of a cleanroom.
The integration under-one-roof saves costs and speed time to market.
OSYPKA AG was founded in 1977 by Prof. Dr.-Ing. E.h. Peter Osypka. It is privately owned and operated together with the charitable „Peter-Osypka Foundation“.
We are proud of our high-quality manufacturing and worldwide marketing of medical devices in the field of cardiology with a product portfolio for electrophysiology, interventional cardiology, and cardiac surgery.
We use our in-house capabilities and services to support our medical device industry partners in the field of cardiology, neurology, orthopedics, and many others.
Our high level of vertical integration provides full control over the design and development of tools, production of components, and assembly of medical products in or out of a cleanroom.
The integration under-one-roof saves costs and speed time to market.
OSYPKA AG was founded in 1977 by Prof. Dr.-Ing. E.h. Peter Osypka. It is privately owned and operated together with the charitable „Peter-Osypka Foundation“.
Company data
Number of employees100-499
Area of business- Components, parts, modules, Original Equipment Manufacturers
- Catheters
- Manufacturing Services
- Services