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Registrations and certificates

Tytex is committed to complying with international industry, environmental and CSR standards and requirements.

We have significant experience in handling the legal requirements and systems to obtain, meet and comply with Medical, Quality, Environmental and Social certificates and registrations.

CE (Class I)

Danish Medicines Agency


ISO

We ensure the dependable high quality of our offerings by ontinually 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.


FDA (USA)

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.


SFDA (China)

Food and Drug Administration. Products manufactured for and delivered to China are registered with the Health Care Authorities and our products and quality are in accordance with all requirements.


Hilfsmittel (Germany)

Post-op bras. Tytex branded products are registered with and have pasted the requirements of the reimbursement authorities in a number of countries, depending on market needs and requests.


PZN (Germany)

Fixations and Safehip. Tytex branded products are registered with and have pasted the requirements of the reimbursement authorities in a number of countries, depending on market needs and requests.


MiGel (Austria)

Post-op bras. Tytex branded products are registered with and have pasted the requirements of the reimbursement authorities in a number of countries, depending on market needs and requests.


e-mediat (Switzerland)

Post-op bras. Tytex branded products are registered with and have pasted the requirements of the reimbursement authorities in a number of countries, depending on market needs and requests.


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