Our Manufacturing Facility
Contura’s state-of-the-art manufacturing facility in Denmark has over 20 years of experience
producing 2.5 iPAAG* injectables. It is fully certified according to EU, US and other international
standards, using proprietary technology and stringent quality control measures to deliver
the highest quality products.
Solely dedicated to the production of 2.5 iPAAG, the facility uses proprietary automated processes to control manufacturing,
including the ALPH (Automated Line for Production of Hydrogel), a one-of-a-kind machine designed specifically for Contura.
ALPH’s advanced capabilities and design reflect our commitment to innovation and excellence in hydrogel production.
We have a team of highly qualified scientists and engineers who oversee the production process and ensure our syringes
are tightly monitored to meet release specifications.
Medical Device Certification
Our manufacturing, quality and final inspection processes have been regulated and approved
by leading Notified Bodies, including TÜV SÜD. These standards allow us to provide 2.5 iPAAG
globally with distribution in the UK, EU, USA, Canada, Australia and beyond.
EC Certificate Annex V 0004 G2S Rev 01
EC Certificate Annex II G1 Rev 02
GMP Authorisation 40290 – DMA
GMP Certificate Korea Exp date 2025 04 26
GMP certifikat Contura, DMA DK V 10000354
ISO 13485 Q5 003953 0001 Rev 03
MDR G12 003953 0009 Rev 00
MDR G70 003953 0006 Rev. 00
MDSAP QS6 003953 0005 Rev. 01
