- Free delivery on orders over 100 BGN.
Medical devices for post-operative care in oncological and aesthetic breast surgeries.
All products from "Carefix" brand range meet international industrial, environmental and corporate standards and requirements. The manufacturing company Tytex has significant experience in handling the legal requirements and systems to obtain, meet and comply with Medical, Quality, Environmental and Social certificates and registrations.
The Tytex way
We have our roots in Europe. It's our base, and that's why we, since our beginning in 2001, have manufactured our products in Slovakia.
We develop and produce all our medical textile products and hospital garments according to EU standards, in EU currencies and with short delivery times. Thanks to our production facilities in Slovakia, our customers benefit not only from a highly skilled work force, but also our ability to keep production costs low. This means quality products at the best prices.
4 awards. 1 in-house value chain
Tytex Slovakia has been awarded 4 times best exporter of Slovakia in the small, middle-sized enterprise category.
How is this possible? Because our entire value chain is in-house: Seamless (weft, circular) and medical mesh (warp, mesh) knitting, sewing, dying, bleaching, packaging and distribution - performing in-process and final release control and providing COA (Certificate of Analysis) or COC (Certifcate of Conformity) for each shipment.
This in-house process means faster through-put for each single medical garment and shorter time to market for our customers.
Tytex Slovakia s.r.o. has a total production area of 13,000 m2 split into two locations, and employs around 500 people.
Take an on site tour at our production premises in Slovakia
Registrations and certificates
https://tytex.com/excellence-in-healthcare-garments/regulations-certifications
Read more about our certificates:
CE (Class I)
Danish Medicines Agency
ISO
We ensure the dependable high quality of our offerings by continually monitoring our processes and procedures. Satisfying the international standards of quality management, ISO 9001, and medical devices, ISO 13485 helps us guarantee the excellence of our products. Furthermore, all Tytex facilities and processes have been certified according to ISO 14001 (environment)
Oeko-Tex (Class II)
Tytex holds the Oeko-Tex Standard 100 certificate showing that all our products are free from harmful substances.
Read more about Oeko-Tex on the official website www.oeko-tex.com
SEDEX
Social Accountability and Ethical Trade. Through the UK based CSR system SEDEX, Tytex work to comply and are regularly audited on SMETA equal to Sedex Membership Ethical Trade Audit.
Countries and certificates
Food and Drug Administration. Products manufactured for and delivered to the Americas are registered with the Health Care Authorities and our products and quality are in accordance with all requirements.
List:
FDA (USA)
CFDA (China)
Hilfsmittel (Germany)
PZN (Germany)
MiGel (Austria)
e-mediat (Switzerland)
