Manufacturing of plastic components and assemblies for catheters in medical device contract manufacturing
KTW Franziska Hönle e.K.
Gewerbestraße 5, 87675 Stötten am AuerbergNew on Amplifa
About KTW Franziska Hönle e.K.
KTW Franziska Hönle e.K. is a sole proprietorship established in 1999, based in Stötten am Auerberg (Allgäu), specializing in contract manufacturing of medical devices. The focus is on processing and finishing medical tubing, wires and pipes as well as producing components for catheter manufacturing, both for peripheral (PTA) and coronary applications (PTCA). The service portfolio includes cutting, shrinking and expanding of plastic tubing including PTFE, proximal and distal balloon shaft manufacturing to customer specifications, crimp sleeves, shrink labels, kink protection and protective sleeves, as well as printing of Luers, markers, shafts, tubing and stainless steel tubes. In addition, the company manufactures prototypes for business partners, develops customer-specific medical devices and technical solutions for manufacturing processes, and acts as an outsourcing partner. Production takes place in an ISO Class 7 cleanroom (EN ISO 14644-1); the company is certified to EN ISO 13485. Materials processed include plastics (particularly PTFE and plastic tubing) as well as stainless steel tubes. Customers come from the medical device and catheter industry in Germany and abroad.
- Site
- Stötten am Auerberg
- Processes
- Processing of medical tubing, Processing of medical wires and pipes, Production of components for catheter manufacturing (peripheral and coronary components), Cutting of plastic tubing (including PTFE), Shrinking of plastic tubing (including PTFE), Expanding of plastic tubing (including PTFE), Proximal and distal balloon shaft manufacturing according to customer specifications, Printing of Luers, markers, shafts, tubing and stainless steel tubes
- Materials
- PTFE (Polytetrafluoroethylene), Plastic tubing (general), Stainless steel (stainless steel tubes), Plastic tubing (medical), Stainless steel
- Certificates
- EN ISO 13485, Cleanroom EN ISO 14644-1 (Class 7)
- Founded
- 1999
- Industries
- Medical technology, Catheter manufacturing (PTA/PTCA)
- 01
Order clarification and design according to customer specifications
- 02
Prototype manufacturing
- 03
Cutting, shrinking and expanding of plastic tubing (including PTFE)
- 04
Balloon shaft manufacturing (proximal/distal)
- 05
Printing of Luers, markers, shafts, tubing and stainless steel tubes
- 06
Manufacturing of crimp sleeves, shrink labels, kink protection and protective
- 07
Assembly of assemblies and customer-specific medical devices in the cleanroom
Materials and Processes
PTFE (Polytetrafluoroethylene)
PTFE plastic tubing is cut, shrunk and expanded, among other things for catheter components.
Plastic tubing (medical)
Base material for tubing, shafts, crimp sleeves, kink protection and protective sleeves.
Stainless steel
Stainless steel tubes are printed and processed as components for catheter manufacturing.
Location
Stötten am Auerberg
DEProduction and administration
- Materials
- Plastic (incl. PTFE), stainless steel
- ISO Class 7 cleanroom (EN ISO 14644-1)
Components
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Processing of medical tubingPlastics | – | – | – | – | Plastics |
| Processing of medical wires and pipesPlastics | – | – | – | – | Plastics, Stainless steel |
| Production of components for catheter manufacturing (peripheral and coronary components)Assembly | – | – | – | – | Plastics |
| Cutting of plastic tubing (including PTFE)Plastics | – | – | – | – | Plastics, PTFE |
| Shrinking of plastic tubing (including PTFE)Plastics | – | – | – | – | Plastics, PTFE |
| Expanding of plastic tubing (including PTFE)Plastics | – | – | – | – | Plastics, PTFE |
| Proximal and distal balloon shaft manufacturing according to customer specificationsPlastics | – | – | – | – | Plastics |
| Printing of Luers, markers, shafts, tubing and stainless steel tubesSurface | – | – | – | – | Plastics, Stainless steel |
| Crimp sleeves, shrink labels, kink protection and protective sleevesPlastics | – | – | – | – | Plastics |
| Prototype manufacturing for business partnersEngineering | – | – | – | – | – |
| Customer-specific medical devices and technical solutions for manufacturing processesAssembly | – | – | – | – | – |
| Manufacturing of components for PTA and PTCA cathetersPlastics | – | – | – | – | Plastics |
Additional services
Quality and Certification
Production takes place in an ISO Class 7 cleanroom in accordance with EN ISO 14644-1. The company is certified to EN ISO 13485; the certificate is available for download.
| Evidence | Stötten am Auerberg |
|---|---|
| EN ISO 13485 | |
| Cleanroom EN ISO 14644-1 (Class 7) |
Company History
- 1999
Founded as a sole proprietorship in medical device contract manufacturing