Bucharest, September 20, 2019

Biosintex, the only Romanian manufacturer of surgical suture materials, the leader of the internal market and important exporter in more than 20 countries worldwide, announces the change of the trade names for several of its medical devices, part of a rebranding strategy with protected trademarks.

After a period of sustained growth of the company Biosintex, it is time to move to a new phase in the activity dedicated to the needs of the health system, doctors and patients.

The proven and recognized excellent quality of our surgical sutures will be complemented by this rebranding that better reflects the values we share with our clients.

The following surgical sutures will be manufactured under the new names:

  • BICRIL, polyglycolic acid multifilament coated absorbable, becomes DACRIL.
  • BICRIL RAPID, polyglycolic acid multifilament coated fast absorbable, becomes DACRIL RAPID.
  • BICRIL 910, poly(glycolide-co-Lactide) (90/10) multifilament coated absorbable, becomes DACRIL 910

  • We will continue to offer same high-quality medical devices that will ensure the safety and comfort of the operative act, as well as the rapid postoperative recovery of patients, as we used to.

    About Biosintex

    Biosintex was founded in 2002 by a family of doctors, with the aim of protecting people’s health and taking part in saving human lives.

    The company produces surgical sutures in a wide range of types and sizes, with or without needle, by using next-generation technology, high quality raw materials, certified by prestigious certification bodies.

    The quality management system is aligned with the international standards in force while the medical devices comply with the latest regulatory requirements regarding safety and performance.

    More information:
    contact@biosintex.com
    Phone: +40 21 2660001
    Web:www.biosintex.com

    BIOSINTEX participates at Arab Health, the largest medical exhibition in the Middle East, which takes place in Dubai, 27th- 30th January 2020. Please, visit us at BOOTH Z5.B41.
    BIOSINTEX participates at Medica – World Forum for Medicine, which takes place in Dusseldorf, Germany, 18th-21th November 2019. Please, visit us at BOOTH 70C01/HALL 7.0STAND C1/HALL 7.

    Biosintex announces the new ISO certification 13485:2016 granted by the prestigious notified body DNV GL Presafe As.

    ISO 13485:2016 is the most current international quality system standard designed specifically for medical device companies.

    This upgrading of certification from previous version ISO 13485:2003 to the new one indicates that Biosintex continues to demonstrated the ability to provide medical devices that consistently meet customer and regulatory requirements.

    All current quality certificates (ISO 9001, ISO 13485 and EC certificates for all medical devices) can be viewed and downloaded from page https://www.biosintex.com/certificari/

    As part of its commitment to manufacture high quality, reliable and innovative medical devices, Biosintex is pleased to announce the granting of new certificates for its quality management system and medical devices.

    On October 12, 2018 Biosintex received from DNV-GL Business Assurance the new ISO ISO 9001:2015 certificate, thus advancing from ISO 9001:2008 to ISO 9001:2015 certification. Upgrading to ISO 9001:2015 certification indicates that the company’s quality management system remains aligned with the current regulatory requirements.

    On November 1, 2018, Biosintex received from DNV-GL Presafe (Notified Body 2460) the new CE mark certificates for all of its medical devices, thus replacing the old CE mark certificates issued by OTDM (Former Notified Body 1868). New CE mark certifications indicates that the medical devices manufactured by Biosintex continues to satisfy the requirements of relevant European Directive MDD 93/42/EEC.

    The new CE mark affixed on all of the medical devices starting November 1st will be CE2460. The medical devices manufactured until November 1st and bearing CE1868 mark remain valid and will be marketed until their expiration date.

    All current quality certificates (ISO 9001, EN ISO 13485 and EC certificates for all medical devices) can be viewed and downloaded from page https://www.biosintex.com/certificari/



    Winner: UMF Carol Davila Bucharest, Medicine; Project manager: Univ. Dr. Bratu Ovidiu Gabriel; grant title: “Local histological changes pre and post-surgery in urinary incontinence effort in women”: 06.03.2018



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