Manufacturer of passive middle ear implants, ventilation tubes and precision instruments for ENT surgery
Heinz Kurz GmbH
72144 Dusslingen (Tübinger Straße 3) · 72144 Dusslingen (Im Steinig 75/1)New on Amplifa
Company
Heinz Kurz GmbH, based in Dusslingen (Baden-Württemberg), has specialized for more than thirty years in the development and manufacture of passive middle ear implants for tympanoplasty and stapedioplasty, ventilation and drainage implants, and special precision instruments with measuring functions. The product range is complemented by implants for rhinology, laryngology and ophthalmology, including eyelid, vocal fold and nasal implants. The delicate prosthesis geometry requires maximum manufacturing precision; strict inspections, an intensive cleaning process for ultra-clean implant surfaces, and MRI safety testing of long-term implants (up to 7.0 Tesla) ensure product quality. Development is science-based, in cooperation with national and international scientists, surgeons and engineers, and is accompanied by extensive measurement and simulation series. In addition to manufacturing, the company offers final packaging after incoming inspection and sterilization as well as worldwide distribution. Since 2021, Heinz Kurz GmbH has been part of the bess group.
- Site
- Dusslingen
- Processes
- Manufacture of passive middle ear implants (prostheses), Cleaning process for implant surfaces, Sterilization/final packaging of medical devices after incoming inspection, Manufacture of surgical instruments with measuring functions, MRI safety testing for long-term implants (up to 7.0 T), Research & Development, Design and Development of Medical Devices, Manufacturing
- Materials
- Nitibond, Nitiflex
- Certificates
- ISO 13485:2016 (MDSAP), MDD 93/42/EEC Annex II (QA system, Class IIb), MDD 93/42/EEC Annex V (QA system), MDR (EU) 2017/745 Notified Body Confirmation Letter, ISO 13485, MDD 93/42/EEC Annex II (Class IIb), MDD 93/42/EEC Annex V, MDR (EU) 2017/745 NB-Confirmation
- Industries
- Medical Technology, ENT (Otology, Rhinology, Laryngology), Ophthalmology
- 01
Research & Development
- 02
Design and Development of Medical Devices
- 03
Manufacturing
- 04
Cleaning Process for Implant Surfaces
- 05
Sterilization
- 06
Incoming Inspection and Final Packaging
- 07
MRI Safety Testing
- 08
Distribution
Materials and Processes
Nitibond
Material from the KURZ implant systems for passive middle ear prostheses.
Nitiflex
Material from the KURZ implant systems for passive middle ear prostheses.
Sites
Tübinger Straße 3, 72144 Dusslingen
DEHeadquarters, Manufacturing
- Materials
- Nitibond, Nitiflex
Im Steinig 75/1, 72144 Dusslingen
DEManufacturing, final packaging after sterilization, finished goods warehouse and shipping warehouse
- Materials
- Nitibond, Nitiflex
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Manufacture of passive middle ear implants (prostheses)Assembly | – | – | – | – | – |
| Cleaning process for implant surfacesSurface | – | – | – | – | – |
| Sterilization/final packaging of medical devices after incoming inspectionAssembly | – | – | – | – | – |
| Manufacture of surgical instruments with measuring functionsMachining | – | – | – | – | – |
| MRI safety testing for long-term implants (up to 7.0 T)Testing | – | – | – | – | – |
Additional services
Quality and Certification
Production is subject to strict inspections and an intensive cleaning process for extremely clean implant surfaces. Quality assurance is certified to ISO 13485:2016 (MDSAP); MRI safety testing of the long-term implants is performed up to 7.0 Tesla.
| Evidence | Tübinger Straße 3, 72144 Dusslingen | Im Steinig 75/1, 72144 Dusslingen |
|---|---|---|
| ISO 13485 | ||
| MDD 93/42/EEC Annex II (Class IIb) | ||
| MDD 93/42/EEC Annex V | ||
| MDR (EU) 2017/745 NB-Confirmation |
History
Active for more than thirty years in the field of passive middle ear implants and precision instruments.
- 2021
Certified to ISO 13485:2016 (MDSAP) since 2021-12-03.
- 2021
Heinz Kurz GmbH becomes part of the bess group.
- 2025
Renewal of the ISO 13485 MDSAP certificate (No. 2214099), valid until 2027-01-01.