Manufacturer and EU authorisation holder of disinfectants and disinfectant wipes for hospital and home care hygiene.
Babgencel GmbH
DüsseldorfNew on Amplifa
About us
Babgencel GmbH, headquartered in Düsseldorf, is a company of the BG Hygiene Group and develops, produces and distributes infection control products for hospital hygiene and home care. The portfolio includes hand and skin disinfection, surface disinfection, disinfectant wipes for medical devices, instrument disinfection as well as nonwoven dry rolls, complemented by XL/XXL dispenser systems for professional use. Originally founded in 2018 as an authorised distributor for the EU sales of its Turkish sister company Kuzey Sağlık, Babgencel has been the licence owner, manufacturer and authorisation holder for biocidal products and medical devices in Europe since the MDR came into force in 2021, managing 18 brands. The group's production takes place at Kuzey Sağlık ve Kimya San. Tic. A.Ş. (founded 2005) and Vento Hygiene Kimya A.Ş. (founded 2020), which also manufacture wet and dry wipes. The quality management system is certified according to ISO 9001:2015, ISO 13485:2016 and ISO 14001:2015; the company is represented at trade fairs such as MEDICA and Arab Health in Dubai.
- Site
- Düsseldorf
- Processes
- Product brochures/download centre, Professional System solutions (XL/XXL dispenser systems), Customer support, Complaint and adverse event management (QA team), Consulting for medical professionals
- Materials
- Biocidal products (disinfectant solutions), Disinfectant and wet wipes, Nonwoven dry rolls, Medical devices under (EU) 2017/745
- Certificates
- ISO 9001:2015, ISO 13485:2016, ISO 14001:2015, MDR (EU) 2017/745 compliance, Green Dot Eco Certificate, MDR (EU) 2017/745
- Founded
- 2018
- Industries
- Healthcare, Hospital hygiene, Home care, Dentistry, Medical device hygiene, Infection control
- 01
R&D and product development
- 02
Regulatory approval (MDR/biocides)
- 03
Production at Kuzey Sağlık or Vento Hygiene
- 04
Quality inspection and release
- 05
Distribution throughout the EU
- 06
Customer support and complaint management
Product groups and formulations
Biocidal products (disinfectant solutions)
Licensed disinfectant solutions for hands, skin, surfaces and instruments.
Disinfectant and wet wipes
Ready-to-use wipes for medical devices, for surfaces as well as wet and dry nonwoven wipes.
Nonwoven dry rolls
Dry rolls as carrier material for disinfectant solutions in professional settings.
Medical devices under (EU) 2017/745
Products with CE marking and full MDR compliance.
Locations
Düsseldorf
DEAdministration, authorisation holder, sales and support
Products
Inside the production
Industries
Additional services
Reference customers
Quality
Product quality and the QM system are continuously monitored and further developed according to ISO 9001:2015, ISO 13485:2016, ISO 14001:2015 and the Medical Device Regulation (EU) 2017/745 (MDR). An in-house QA team handles complaint and adverse event management.
| Evidence | Düsseldorf |
|---|---|
| ISO 9001:2015 | |
| ISO 13485:2016 | |
| ISO 14001:2015 | |
| MDR (EU) 2017/745 | |
| Green Dot Eco Certificate |
History
- 2005
Founding of Kuzey Sağlık ve Kimya San. Tic. A.Ş. (joint stock company), cornerstone of the BG Hygiene Group
- 2007
Licensed manufacturer of biocidal products; first CE certification for disinfectants for medical devices
- 2018
Founding of Babgencel GmbH in Düsseldorf as authorised distributor for EU sales
- 2020
Founding of Vento Hygiene Kimya A.Ş. to expand production capacities (wet/dry wipes, disinfectant wipes)
- 2021
With the entry into force of the MDR (EU) 2017/745, established as licence owner and manufacturer of disinfectant solutions and wipes