Collagen is the most abundant protein in mammal tissue.
Bovine Collagen type I has been used for centuries in medical applications. It is a key raw material for numerous medical devices and can for example be found as Surgical haemostatics, in Bone Void Filler, dermal regeneration matrices… It can be sourced from different animal species, and tissues.
Bovine Collagen Type I, the most widely used collagen, it can be found in different forms, with different characteristics, from insoluble native collagen fibres to soluble collagen solutions. Each collagen raw material form exhibit specific properties to allow for tailor made collagen medical devices for a specific need:
– insoluble native collagen fibres for application like surgical hemostasis and wound Healing,
– soluble collagen solutions for anti-adhesion film,
– coating of medical devices…
SYMATESE has extracted and transformed bovine collagen Type I for more than 30 years in compliance with sanitary and regulatory requirements requested for medical applications (purity, traceability, certificates).
SYMATESE deliver a premium bovine Collagen type I used in many collagen based medical devices Medical devices. Manufacturing by SYMATESE are is in compliance with the standard NF EN ISO 22442 parts 1 to 3 (2016).
SYMATESE also extracts collagen from different tissues (hides, tendons, kidney or kneecap) and from different animal species (bovine, porcine, equine or fish). For products of bovine origin, SYMATESE has validated two sourcing : from US and from Australia.
SYMATESE’s bovine collagen raw material is also in compliance with the European requirements:
– Regulation (UE) N° 722/2012 of 8 August 2012 concerning particular demands with regards to the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin;
– Monograph N° 1483 of European Pharmacopieia : « Products with risk of transmitting agents of animal spongiform encephalopathies ». SYMATESE has obtained a certificate of suitability for its 2 bovine collagen Type I raw materials.
The risk management process implemented by SYMATESE guarantees complete microbiological safety to the users.
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