Service provider for laser marking, cleaning, passivation, packaging and labeling of medical devices
add'n solutions GmbH & Co. KG
Wurmlingen (Max-Planck-Str. 12)New on Amplifa
About add'n solutions
add'n solutions GmbH & Co. KG is a specialized service provider based in Wurmlingen near Tuttlingen, focused on downstream processing of medical devices. The company offers laser marking according to the UDI requirements of the FDA and MDR (direct part marking/DPM), final cleaning in accordance with ASTM A380, passivation in accordance with ASTM A380 and A967, as well as packaging, labeling and standards-compliant barcode verification. The processes are validated and designed to meet the requirements of medical technology; they can also be applied to components from other industries. The parts processed are predominantly reusable surgical instruments made of stainless steel. A fully automatic, validated cleaning and passivation system is available for cleaning and passivation. The company was founded in 2016 and now marks more than 750,000 products per year for over 220 active customers; in the Tuttlingen region and surrounding area, a free collection and delivery service is offered.
- Site
- Wurmlingen
- Processes
- Laser marking / laser marking (UDI/DPM), Cleaning (final cleaning according to ASTM A380), Passivation according to ASTM A380 and A967, Packaging, Labeling, Barcode verification (barcode quality standards), Laser marking (UDI/DPM according to FDA and MDR requirements), Cleaning (ASTM A380)
- Materials
- Surgical instruments (stainless steel, implied), Stainless steel, Cleaning according to ASTM A380, Passivation according to ASTM A380/A967, Laser marking UDI/DPM
- Certificates
- DIN EN ISO 13485, ISO 13485
- Founded
- 2016
- Employees
- More than 25
- Industries
- Medical technology (reusable surgical instruments)
- 01
Collection and delivery service (regional)
- 02
Laser marking (UDI/DPM)
- 03
Cleaning in accordance with ASTM A380
- 04
Passivation in accordance with ASTM A380 and A967
- 05
Inspection and verification of barcodes
- 06
Labeling
- 07
Packaging
Materials and Processes
Stainless steel
Material of reusable surgical instruments for laser marking, cleaning and passivation.
Cleaning according to ASTM A380
Validated final cleaning in the fully automatic cleaning and passivation system.
Passivation according to ASTM A380/A967
Passivation to optimize the corrosion protection of the instruments.
Laser marking UDI/DPM
Direct part marking according to FDA and MDR requirements using several laser types.
Locations
Wurmlingen
DEHeadquarters and production site
- Materials
- Stainless steel
- Fully automatic cleaning and passivation system
- Laser marking systems
- Barcode scanner/verification technology
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Laser marking / laser marking (UDI/DPM)Surface | – | – | – | – | – |
| Cleaning (final cleaning according to ASTM A380)Surface | – | – | – | – | – |
| Passivation according to ASTM A380 and A967Surface | – | – | – | – | – |
| PackagingAssembly | – | – | – | – | – |
| LabelingAssembly | – | – | – | – | – |
| Barcode verification (barcode quality standards)Inspection | – | – | – | – | – |
3 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| Cleaning and passivation system (fully automatic) | – | 1 | – | – | Wurmlingen |
| Laser marking system | FOBA (reference www.fobalaser.com, uncertain) | – | – | – | Wurmlingen |
| Barcode scanner/verification technology | – | – | – | – | Wurmlingen |
Additional services
Quality
All processes are validated and continuously monitored; tests such as in-vitro cytotoxicity, bioburden determination, particle analysis, THC and TOC are regularly performed by accredited laboratories. The company is certified to DIN EN ISO 13485 and has published the first study on the long-term durability of UDI laser markings on surgical instruments.
| Evidence | Wurmlingen |
|---|---|
| ISO 13485 |
History
- 2016
Founding of add'n solutions GmbH & Co. KG in the context of coming to terms with the UDI directive
- 2025
More than 9 years in the market, over 220 active customers, over 750,000 marked products per year and more than 25 employees