Manufacture of own silicone medical devices for ENT and head and neck surgery

bess medizintechnik gmbh

Berlin (Head Office/Sales) · Berlin (Production bess pro gmbh)New on Amplifa

1988Founded

Silicone, Bioactive glass S53P4Materials

BerlinSites

About bess medizintechnik

bess medizintechnik gmbh has been a partner in ENT and head and neck surgery since 1988, based in Berlin. As part of the bess group, the company is closely linked to its sister companies Leufen Medical (Germany), Novatech (France) and Boston Medical Products (USA). High-quality own products Made in Germany are manufactured by the production company bess pro gmbh in Berlin, including non-active implants made of soft tissue such as silicone stents (e.g. aerstent/aixstent), non-vascular stents for respiratory applications as well as non-implantable devices for wound and skin care (bess folio, FOLIOXANE). Materials are implantable (unrestricted) silicone and bioactive glass S53P4. The sales program covers laryngology and tracheal surgery products (Montgomery Safe-T-Tube, LACS, tracheostomy tubes), rhinology products, bone substitute material Bonalive granules CMF and endoscopy systems. An in-house team of development engineers realizes new product developments, supported by quality management according to DIN EN ISO 13485 and the MDR. The field sales team serves clinics and practices in Germany and Austria.

Site: Berlin
Processes: Manufacture of non-active implants made of soft tissue and other implants (e.g., Manufacture of non-active, non-implantable devices for wound and skin care (bess folio,, Manufacture of non-vascular stents (respiratory stents, esophageal, duodenal,, Manufacture of ENT products (ventilation tubes, nasal splints, rhinology catheters), Manufacture of non-implantable guiding catheters, balloon catheters, guidewires, introducers, Production of own medical devices Made in Germany (bess pro gmbh), Product development with in-house team of development engineers, Sales with field service for clinics and practices (Germany and Austria)
Materials: Silicone (implantable 'unrestricted' silicone), Bioactive glass S53P4, Bioactive glass S53P4 (composition: 53% SiO2, 23% Na2O, 20% CaO, 4% P2O5), Silicone (implantable unrestricted silicone), Bioactive glass S53P4 (53% SiO2, 23% Na2O, 20% CaO, 4% P2O5)
Certificates: DIN EN ISO 13485:2021 / EN ISO 13485:2016 A11:2021 / ISO 13485:2016, MDR QM certificate (EU 2017/745, Annex IX), EC Certificate MDD (93/42/EEC, full quality assurance system), MDD EC certificate (93/42/EEC, full quality assurance system)
Founded: 1988
Industries: Medical technology, ENT (otorhinolaryngology), Head and neck surgery, Otology, Rhinology, Laryngology/tracheal surgery

01
Product development (in-house team of development engineers)
02
Manufacture of own medical devices (bess pro gmbh)
03
Sales with field service for clinics and practices (Germany and Austria)
04
e-Labelling (electronic instructions for use)

Materials and Processes

Silicone (implantable unrestricted silicone)

Implantable silicone for stents, tubes and soft tissue implants in laryngology and tracheal surgery.

S53P4

Bioactive glass S53P4 (53% SiO2, 23% Na2O, 20% CaO, 4% P2O5)

Bioactive glass for bone substitute material Bonalive granules CMF, with antibacterial and osteoconductive properties.

Sites

Berlin (Head Office/Sales)

Head office / Sales bess medizintechnik gmbh

Berlin (Production bess pro gmbh)

Production bess pro gmbh, Gustav-Krone-Str. 7

Materials: Silicone

Components

**LACS - Laryngeal Anterior Commissure Stent (silicone stent)**Silicone molded parts manufacturing · Laryngology

**Velnez fragmenting nasal packing**Silicone · Rhinology

**Bonalive granules CMF - bone substitute material**Bioactive glass S53P4 · Oral and maxillofacial surgery

**Ductoscopy - Modular microendoscope**Microendoscopy · Endoscopy

Inside the production

Industries

Medical technologyENT (otorhinolaryngology)Head and neck surgeryOtologyRhinologyLaryngology/tracheal surgeryOral and maxillofacial surgeryEndoscopyMicroendoscopy

Processes & technical limits

Processes	Tolerance	Max. part	Weight	Lot size	Materials
Manufacture of non-active implants made of soft tissue and other implants (e.g.Plastics	–	–	–	–	Silicone
Manufacture of non-active, non-implantable devices for wound and skin care (bess folio,Plastics	–	–	–	–	Silicone
Manufacture of non-vascular stents (respiratory stents, esophageal, duodenal,Plastics	–	–	–	–	Silicone
Manufacture of ENT products (ventilation tubes, nasal splints, rhinology catheters)Plastics	–	–	–	–	Silicone
Manufacture of non-implantable guiding catheters, balloon catheters, guidewires, introducersPlastics	–	–	–	–	–

Additional services

Production of own medical devices Made in Germany (bess pro gmbh)Product development with in-house team of development engineersSales with field service for clinics and practices (Germany and Austria)e-Labelling (electronic instructions for use)

Quality

The production company bess pro gmbh operates a certified quality management system according to DIN EN ISO 13485 and in accordance with the EU Medical Device Regulation MDR (Annex IX) at the notified body DQS Medizinprodukte GmbH (NB 0297). This covers the manufacture of non-active implants made of soft tissue, non-implantable devices for wound and skin care, and non-vascular stents.

Evidence	Berlin (Production bess pro gmbh)
DIN EN ISO 13485:2021 / EN ISO 13485:2016 A11:2021 / ISO 13485:2016
MDR QM certificate (EU 2017/745, Annex IX)
MDD EC certificate (93/42/EEC, full quality assurance system)

History

1988
bess medizintechnik founded as a partner in ENT and head and neck surgery
Part of the bess group with sister companies Heinz Kurz GmbH (passive middle ear implants), Leufen Medical (Germany), Novatech (France) and Boston Medical Products (USA)