Manufacturing and distribution of surgical instruments and endoscopy systems for ENT and Head & Neck surgery

FENTEXmedical GmbH

Neuhausen ob EckNew on Amplifa

GmbHLegal form

HRB 451410, Amtsgericht StuttgartCommercial register

Neuhausen ob EckLocation

ISO 13485QM certification

About FENTEXmedical

FENTEXmedical GmbH is a medical technology company based in Neuhausen ob Eck near Tuttlingen, the world-renowned center of surgical instrument engineering. The company specializes in the development, manufacture and distribution of surgical instruments and endoscopy systems for ENT physicians and Head & Neck surgeons. The product portfolio comprises rigid and flexible endoscopes as well as instruments for otology, paranasal sinus surgery (FESS), rhinology, oral cavity surgery and laryngology, including the LARS 2.0 Retractor System (Larynx Advanced Retractor System). In addition, FENTEXmedical offers a repair and exchange service for damaged rigid and flexible endoscopes. The products are predominantly manufactured in Germany (Made in Germany) and, thanks to high-quality components, are designed to ensure precision, reliability and durability. The company operates a quality management system certified to DIN EN ISO 13485 and offers personal consultation as well as long-term support.

Site: Neuhausen ob Eck
Processes: Manufacturing of surgical instruments for ENT/Head & Neck (rigid and flexible endoscopes,, Repair and exchange of rigid or flexible endoscopes, Repair and exchange of rigid and flexible endoscopes, Manufacturing of surgical instruments and endoscopy systems, Personalized consultation and long-term support
Certificates: ISO 13485:2016 (DIN EN ISO 13485:2021), ISO 13485
Industries: Medical technology, ENT (Otorhinolaryngology), Head & Neck surgery

01
Development and design
02
Manufacturing
03
Quality inspection
04
Distribution
05
Repair and exchange service

Locations

Neuhausen ob Eck

Headquarters: development, manufacturing and distribution

Products and Components

**Rigid and flexible endoscopes**Endoscopy · ENT surgery

**Otology instruments**Surgical instruments · Otology

**Instruments for paranasal sinus surgery**Surgical instruments · FESS

**Rhinology instruments**Surgical instruments · Rhinology

**Oral cavity instruments**Surgical instruments · Oral cavity surgery

**Laryngology instruments**Surgical instruments · Laryngology

Inside the production

Endoscopy – precise visualization for diagnosis and surgery

Otology – instruments for microsurgical procedures

Sinus surgery – minimally invasive procedures on the paranasal sinuses

Rhinology – instruments for nasal surgery

Oral cavity – instruments for oral cavity surgery

Laryngology – instruments for procedures on the larynx

Industries

Medical technologyENT (Otorhinolaryngology)Head & Neck surgery

Processes & technical limits

Processes	Tolerance	Max. part	Weight	Lot size	Materials
Manufacturing of surgical instruments for ENT/Head & Neck (rigid and flexible endoscopes,Assembly	–	–	–	–	–
Repair and exchange of rigid or flexible endoscopesAssembly	–	–	–	–	–

Additional services

Repair and exchange of rigid and flexible endoscopesManufacturing of surgical instruments and endoscopy systemsPersonalized consultation and long-term support

Quality

FENTEXmedical maintains a quality management system certified to DIN EN ISO 13485:2016 (incl. DIN EN ISO 13485:2021), audited by DQS Medizinprodukte GmbH. The scope covers the development, manufacture and distribution of non-sterile, non-active flexible and rigid endoscopes as well as surgical instruments.

Evidence	Neuhausen ob Eck
ISO 13485