H. + H. Maslanka Chirurgische Instrumente GmbH

About Maslanka

H. + H. Maslanka Chirurgische Instrumente GmbH has been manufacturing surgical instruments and medical devices for endoscopy since 1974, including biopsy forceps, grasping forceps, foreign body forceps, polypectomy snares, stone baskets, catheters, puncture needles, probes and applicators. The product range covers the fields of cardiology, gastroenterology, laparoscopy and urology and includes both reusable and single-use products. In addition to series production, the company offers customer-specific project developments of instruments and devices, including in-house development of the tools for product manufacturing, as well as OEM manufacturing for medical technology companies. Production takes place with modern production equipment and trained specialist staff at the headquarters in Tuttlingen on approx. 2,000 m² of production and office space. Maslanka is involved in new developments and further developments of renowned medical technology companies and can look back on numerous patents, among others on the double-lumen probe for fibrin glueing. Customers include Ovesco Endoscopy AG (patent-protected instrument) and Hemostat Medical GmbH (UniTip applicators).

Site

Tuttlingen

Processes

Customer-specific development of medical instruments and devices (incl. tools for, Production of surgical instruments and single-use products for endoscopy (OEM manufacturing), Customer-specific development of instruments and devices (project development), In-house tool development for product manufacturing, OEM manufacturing, Production of single-use and reusable products

Materials

OEM manufacturing, Project development

Certificates

DIN EN ISO 13485:2021 / ISO 13485:2016, EU QMS Certificate MDR Annex IX Chapter I and III, EU Technical Documentation Assessment Certificate MDR Annex IX Chapter II, EC Certificate Annex II Directive 93/42/EEC (Quality Assurance System), ISO 13485, EU MDR (Annex IX Chapter I and III), EU MDR (Annex IX Chapter II, Class III)

Founded

1974

Industries

Medical technology / Endoscopy, Cardiology, Gastroenterology, Laparoscopy, Urology

1. 01

   Project development and design of instruments and devices

2. 02

   In-house tool development for product manufacturing

3. 03

   Manufacturing of instruments and single-use products

4. 04

   Assembly

5. 05

   Quality management and sales

Materials and Processes

Locations

Processes & technical limits

Quality

The quality assurance system in accordance with DIN EN ISO 13485 covers the development, production and sale of surgical instruments and is audited and monitored by notified bodies (DQS Medizinprodukte GmbH, mdc medical device certification GmbH).

History

1. 1974

   Founded by Harald and Hermann Maslanka; production of surgical instruments and biopsy forceps for endoscopy

2. 1980/1981

   New building and relocation to Stockacherstraße 172

3. 1983

   Development of the double-lumen probe for fibrin glueing

4. 1990

   Start of production of cardiology instruments

5. 1991

   Expansion with extension of the production area to 800 sqm

6. 1996

   Introduction of a QM system

7. 1997

   Development of the production of single-use products

8. 2000

   Extension added to the existing company building

9. 2003

   OEM manufacturing

10. 2006

    Occupancy of the annex building

11. 2011

    Addition of another storey to the main building

12. 2014

    Extension of the warehouse to approx. 2,000 sqm of production and office space