Development and distribution of the hydraulic cervical dilator Gynedil for gynaecology
D.Med Healthcare Germany AG
DüsseldorfNew on Amplifa
About D.Med Healthcare Germany AG / Gynedil
D.Med Healthcare Germany AG, headquartered in Düsseldorf, is the manufacturer of Gynedil, a hydraulic dilation system for dilation of the cervical canal in gynaecology. The single-use device consists of a manually operated, pistol-shaped hydraulic pump made of medical-grade plastic with an integrated distilled-water reservoir and piston pump, as well as a flexible balloon dilator made of medical-grade, latex-free silicone that is stabilised by a high-strength, reinforced polyethylene fabric. When the trigger is pressed, pressurised distilled water is injected into the balloon, which expands laterally and without friction; the pump chamber generates a pressure of around 20 bar. The product is gamma-sterilised, CE-marked and patent-protected. Gynedil is distributed to gynaecologists and clinics; the dilation takes 20 to 30 seconds and requires only a single insertion.
- Site
- Düsseldorf
- Processes
- Hydraulic cervical dilation (Gynedil, single-use device, gamma-sterilised)
- Materials
- Medical-grade plastic, Medical-grade silicone (latex-free), Polyethylene fabric (high-strength, reinforced)
- Certificates
- CE marking
- Employees
- 51–200
- Industries
- Medical technology, Gynaecology
- 01
Development and design
- 02
Manufacturing from medical-grade plastic and silicone
- 03
Gamma sterilisation
- 04
CE marking
- 05
Distribution and marketing
Materials and Functional Principle
Medical-grade plastic
Manually operated, pistol-shaped hydraulic pump including handle, water reservoir and piston pump.
Medical-grade silicone (latex-free)
Balloon dilator made of latex-free medical-grade silicone, causes no allergies or irritation.
Polyethylene fabric (high-strength, reinforced)
The reinforced fabric determines the final dilation geometry and, according to the manufacturer, is seven times stronger than steel fabric of the same thickness.
Locations
Düsseldorf
DEHeadquarters
Product Components
Inside the production
Industries
Additional services
Quality and Certification
Gynedil is CE-marked, patent-protected and supplied gamma-sterilised as a single-use product; manufacturing is carried out exclusively from medical-grade materials.
| Evidence | Düsseldorf |
|---|---|
| CE marking |
History
- 1789
Beginning of mechanical dilation with Hegar metal dilators – historical context that Gynedil cites as a reference to the previous standard method