Surgical instruments and sterilization containers with in-house finish line, laser marking and validated final cleaning
AS Medizintechnik GmbH
Sattlerstraße 15, 78532 Tuttlingen · Industriestrasse 26, 78532 TuttlingenNew on Amplifa
The Company
AS Medizintechnik GmbH is a family-run company based in Tuttlingen, the world center of medical technology, which has been distributing and refining surgical instrumentation since 1998. The portfolio comprises around 18,000 standard and specialty instruments for surgery, instruments for osteosynthesis, microsurgery and arthroscopy, as well as the specially developed asipco® sterilization container system. The instruments are primarily manufactured in Tuttlingen by selected production partners, made from corrosion-resistant stainless steels in accordance with DIN EN ISO 7153-1 as well as titanium, PEEK and aluminium. On-site, the company performs quality control (hardness and boil test), glass bead blasting, ultra-short-pulse laser marking with UDI GS1 DataMatrix, validated final cleaning, passivation and packaging. Through a network of authorized distribution partners, AS is represented in more than 70 countries and meets the requirements of the MDR (EU) 2017/745.
- Site
- Tuttlingen
- Processes
- Ultra-short-pulse laser marking (UDI DataMatrix, corrosion-free), Glass bead blasting / matting (glare-free surface), Passivation (citric acid-based) and corrosion protection, Pre-cleaning in ultrasonic bath, Validated final cleaning and thermal disinfection per DIN EN ISO 13485 (RDG, A0-3000, 90°C, 5, Laser welding, Hardness testing (Rockwell method) and boil test for corrosion resistance control, UDI GS1 DataMatrix verification (ISO/IEC 29158, TR29158)
- Materials
- Corrosion-resistant stainless steels, TITANIUM, PEEK, Aluminium, DLC coating, Titanium
- Certificates
- DIN EN ISO 13485, MDR (EU) 2017/745, Annex IX, Chapters I and III, Annex II without Section 4 EC 93/42 EEC, Annex V, Section 3 EC 93/42 EEC, GS1 Germany certificate, MDR (EU) 2017/745, Annex IX
- Founded
- 1998
- Industries
- Medical technology, Hospitals, Surgery, Medical wholesale trade, Medical wholesale trade and distributors
- 01
Manufacturing by selected production partners in Tuttlingen
- 02
Incoming goods inspection: drawing comparison, hardness testing, boil test
- 03
Glass bead blasting for glare-free matting
- 04
Ultra-short-pulse laser marking (UDI GS1 DataMatrix)
- 05
Pre-cleaning in ultrasonic bath
- 06
Validated final cleaning and thermal disinfection in washer-disinfector incl.
- 07
Laser welding for repairs
- 08
Final inspection, functional and cutting tests, oiling, packaging, labeling
- 09
Assembly and storage of asipco® containers
- 10
Logistics and shipping via distribution partners
Materials and Processes
Corrosion-resistant stainless steels
Standard material for surgical instruments, every batch tested for hardness and corrosion resistance.
Titanium
For micro-instruments, laser-markable and corrosion-free marking.
PEEK
Plastic material for variants of micro-instruments.
Aluminium
High-quality material of the asipco® sterilization container system, lids machined from solid aluminium block.
DLC coating
Coating of instruments, markable corrosion-free by ultra-short-pulse laser.
Sites
Sattlerstraße 15, Tuttlingen
DEHeadquarters, administration, production, logistics
- Materials
- Stainless steel, titanium, PEEK
- Ultra-short-pulse laser marking machines
- Laser welding machine
- 4 BELIMED cleaning and disinfection machines
- 2 ultrasonic cleaning tanks
- UDI DataMatrix verification camera (ISO/IEC 29158)
Industriestrasse 26, Tuttlingen
DEWarehouse and assembly of asipco® sterilization containers
- Materials
- Aluminium
Products and Components
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Ultra-short-pulse laser marking (UDI DataMatrix, corrosion-free)Surface | – | – | – | – | Stainless steel, TITANIUM, Aluminium, PEEK, DLC-coated instruments |
| Glass bead blasting / matting (glare-free surface)Surface | – | – | – | – | Stainless steel |
| Passivation (citric acid-based) and corrosion protectionSurface | – | – | – | – | Stainless steel |
| Pre-cleaning in ultrasonic bathSurface | – | – | – | – | Stainless steel |
| Validated final cleaning and thermal disinfection per DIN EN ISO 13485 (RDG, A0-3000, 90°C, 5Surface | – | – | – | – | Stainless steel |
| Laser weldingJoining | – | – | – | – | Stainless steel |
| Hardness testing (Rockwell method) and boil test for corrosion resistance controlTesting | – | – | – | – | Stainless steel |
| UDI GS1 DataMatrix verification (ISO/IEC 29158, TR29158)Testing | – | – | – | – | – |
| Final inspection, functional and cutting tests, oiling, packaging, labelingTesting | – | – | – | – | – |
| Assembly of asipco® sterilization containers (lids machined from aluminium block)Assembly | – | – | – | – | Aluminium |
| Manufacture of surgical instruments by selected production partners (manufacturing methods andEngineering | – | – | – | – | corrosion-resistant stainless steels |
| Repair service for surgical instrumentsEngineering | – | – | – | – | – |
| Configuration of OR sets and individual instruments (approx. 18,000 products)Engineering | – | – | – | – | – |
5 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| Ultra-short-pulse laser marking machine | – | – | – | – | Tuttlingen |
| Laser welding machine | – | 1 | – | 2016 | Tuttlingen |
| Cleaning and disinfection machine (washer-disinfector) | BELIMED | 4 | – | 2013 (3), | Tuttlingen |
| Ultrasonic cleaning tanks | – | 2 | – | – | Tuttlingen |
| UDI DataMatrix verification camera (calibrated, ISO/IEC 29158) | – | – | – | – | Tuttlingen |
Additional services
Reference customers
Quality
Every instrument is tested for conformance to drawing and function, and every steel batch for hardness (Rockwell) and corrosion resistance (boil test). The UDI DataMatrix marking is spot-checked with a calibrated camera in accordance with ISO/IEC 29158; the final cleaning is validated in accordance with DIN EN ISO 13485.
| Evidence | Sattlerstraße 15, Tuttlingen |
|---|---|
| DIN EN ISO 13485 | |
| MDR (EU) 2017/745, Annex IX | |
| GS1 Germany certificate |
Company History
- 1998
Foundation of AS Medizintechnik GmbH by Andreas Schilling in Tuttlingen, portfolio of approx. 12,000 instruments
- 2001
Move into new premises at Sattlerstraße 15 in Tuttlingen-Nendingen
- 2002
Portfolio of approx. 16,000 items, start of international sales
- 2004
First printed edition of the surgery main catalog
- 2007
Specialist dealer network in approx. 50 countries, portfolio of approx. 18,000 items, move into the AS main building
- 2008
2nd generation surgery main catalog, investment in the first laser marking system
- 2011
Purchase of a building at Industriestrasse 26 for warehouse expansion; assembly of asipco® containers
- 2012
3rd generation of the surgery main catalog
- 2013
Installation of 3 BELIMED cleaning and disinfection machines for validated final cleaning per DIN EN ISO 13485
- 2015
Network in approx. 60 countries, portfolio of approx. 20,000 items, 3rd extension completed
- 2016
Investment in two laser machines and a laser welding machine
- 2017
Presentation of the asipco® sterilization container system, reddot design award, introduction of GS1-UDI
- 2018
20 years of AS Medizintechnik; member of DIN e.V.
- 2020
Expansion of the laser department with additional ultra-short-pulse lasers
- 2021
Installation of an additional BELIMED cleaning and disinfection machine
- 2023
25th company anniversary; MDR (EU) 2017/745 approval of Class 1 and 1R products