Manufacturer of cornea implants made of natural porcine cornea collagen for corneal and refractive surgery

Gebauer Medizintechnik GmbH

75242 Neuhausen (Enz district), GermanyNew on Amplifa

Over 40 years of experience inHistory

ISO 13485, MDR (EU 2017/745)Certification

< 2 mm diameter, < 30 µm thicknessImplant component size

HRB 504484, Registered court MannheimCommercial register

About Gebauer Medizintechnik

Gebauer Medizintechnik GmbH is a medical technology company based in Neuhausen in the Enz district near Stuttgart. Under the XENIA brand, cornea implants for corneal and refractive surgery are manufactured, in particular implants for the treatment of presbyopia. The implant material consists of natural cornea collagen of porcine origin and is purified by a biochemical decellularization process that removes foreign cells, epitopes and antigens, and subsequently stabilized by a proprietary crosslinking process. The implants are smaller than 2 mm in diameter and thinner than 30 µm and are also manufactured to patient-specific specifications. Production takes place at the Neuhausen site under an ISO 13485-certified quality management system and in accordance with the EU Medical Device Regulation (EU) 2017/745 (MDR). The company looks back on over 40 years of innovation and expertise in ophthalmology.

Site: Neuhausen / Enz district
Processes: Manufacture of cornea implants from natural cornea collagen (porcine), Biochemical decellularization process (removal of foreign cells, epitopes, antigens), Proprietary crosslinking process for stabilization of the material, Product demonstrations, Customer-specific implant specification (Request Form)
Materials: Natural cornea collagen (porcine origin)
Certificates: ISO 13485, MDR compliance (EU 2017/745)
Industries: Medical technology, Ophthalmology, Corneal and refractive surgery, Ophthalmology/Corneal and refractive surgery

01
Procurement of porcine cornea collagen
02
Biochemical decellularization process (removal of foreign cells, epitopes,
03
Proprietary crosslinking process for stabilization
04
Manufacture and patient-specific production of the implants
05
Quality inspection and delivery upon prescription (Request Form)

Material and Process

XENIA

Natural cornea collagen (porcine origin)

Basis for cornea implants; purified and stabilized after decellularization and crosslinking for additive corneal surgery.

Site

Neuhausen (Enz district)

Production and administration (manufacturing near Stuttgart)

Part weight / size: < 2 mm diameter, < 30 µm thickness
Materials: Porcine cornea collagen

Components

**XENIA cornea implant (presbyopia)**Collagen implant · Ophthalmology

Inside the production

XENIA Technology – Corneal Tissue Engineering

Industries

Medical technologyOphthalmologyCorneal and refractive surgeryOphthalmology/Corneal and refractive surgery

Processes & technical limits

Processes	Tolerance	Max. part	Weight	Lot size	Materials
Manufacture of cornea implants from natural cornea collagen (porcine)Engineering	–	< 2 mm (implant diameter) × < 2 mm × < 30 µm (thickness)	–	–	Porcine cornea collagen
Biochemical decellularization process (removal of foreign cells, epitopes, antigens)Engineering	–	–	–	–	Porcine cornea collagen
Proprietary crosslinking process for stabilization of the materialEngineering	–	–	–	–	Porcine cornea collagen

Additional services

Product demonstrationsCustomer-specific implant specification (Request Form)

Quality

The products are manufactured under an ISO 13485-certified quality management system and comply with the EU Medical Device Regulation (EU) 2017/745 (MDR). Experienced, specialized employees ensure product quality from the decellularization process to the finished implant.

Evidence	Neuhausen (Enz district)
ISO 13485
MDR compliance (EU 2017/745)

History

Over 40 years of innovation and expertise in ophthalmology