Manufacturing of surgical suture materials, needles, meshes, hemostatic agents and packaging solutions for disposable surgical products.
LINXObere Medizintechnik GmbH
Bremen (Oberneuland)New on Amplifa
About LINXObere Medizintechnik
LINXObere Medizintechnik GmbH is a medical technology company based in Bremen-Oberneuland that specializes in devices and packaging solutions for disposable surgical products. The manufacturing portfolio includes surgical sutures, surgical needles, meshes and hemostatic agents as well as angioplasty products and wound closure products across three product areas: Wound Closure Management, Surgical Consumables and Angioplasty Products. The company's core goes back to a group with 35 years of experience in the medical field, consisting of physicians and medical engineers focused on clinical research and development of needle alloys for surgical suture materials. In addition to manufacturing its own products under the LINXObere brand, the company offers consulting for suture manufacturers on raw materials, technology transfer of German high-tech manufacturing, and process development. The manufacturing processes are automated and follow German standards; the products are sold in countries worldwide.
- Site
- Bremen
- Processes
- Manufacturing of surgical suture materials (Surgical Sutures), Manufacturing of surgical needles (Surgical Needles), Manufacturing of surgical meshes (Surgical Meshes), Manufacturing of surgical hemostatic agents (Surgical Hemostatic agents), Packaging solutions for disposable surgical products (packaging solutions for disposable surgical, Process development (process development), Automated manufacturing of Wound Closure Management, Surgical Consumables and, Consulting for suture manufacturers on raw materials
- Materials
- N-Butyl-2-Cyanoacrylate, Needle alloys for surgical needles
- Certificates
- CE, ISO 13485 / QMS Certificate (Class IIIB), WHO GMP, US FDA approval, CE certification (no. 310562, Class III), QMS Certificate Class IIIB (no. 310563), US FDA, ISO 13485
- Industries
- Medical technology, Surgery, Wound closure, Angioplasty
- 01
Clinical R&D / consulting on raw materials
- 02
Process development
- 03
Automated manufacturing of surgical products
- 04
Packaging solutions for disposable surgical products
- 05
International sales and market launch
Materials & Processes
Needle alloys for surgical needles
Alloys for surgical needles, further developed through clinical R&D for suture materials.
N-Butyl-2-Cyanoacrylate
Topical tissue adhesive for fast and secure wound closure (product MagicDrop).
Sites
Bremen-Oberneuland
DEHeadquarters / Manufacturing
- Materials
- Needle alloys, N-Butyl-2-Cyanoacrylate
Products & Components
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Manufacturing of surgical suture materials (Surgical Sutures)Assembly | – | – | – | – | Needle alloys (needle alloys) |
| Manufacturing of surgical needles (Surgical Needles)Assembly | – | – | – | – | Needle alloys (needle alloys) |
| Manufacturing of surgical meshes (Surgical Meshes)Assembly | – | – | – | – | – |
| Manufacturing of surgical hemostatic agents (Surgical Hemostatic agents)Assembly | – | – | – | – | – |
| Packaging solutions for disposable surgical products (packaging solutions for disposable surgicalAssembly | – | – | – | – | – |
| Process development (process development)Engineering | – | – | – | – | – |
| Automated manufacturing of Wound Closure Management, Surgical Consumables andAssembly | – | – | – | – | – |
Additional services
Quality & Certifications
The manufacturing facilities are approved according to ISO, WHO GMP and US FDA and CE certified; an MD-EC Design Certificate (no. 310562, Class III) and a QMS Certificate (no. 310563, Class IIIB) are held.
| Evidence | Bremen-Oberneuland |
|---|---|
| CE certification (no. 310562, Class III) | |
| QMS Certificate Class IIIB (no. 310563) | |
| WHO GMP | |
| US FDA | |
| ISO 13485 |
History
Foundation of the group's core with 35 years of experience in the medical field in Bremen-Oberneuland; focus on clinical R&D on needle alloys for surgical suture materials
Establishment of the company's own manufacturing site as LINXObere Medizintechnik GmbH to oversee the production of surgical sutures under its own brand