Activity

  • Central Venous Catheter (CVC) manufactured in the United States and sold only in Europe
    Class IIb/Class III Medical Device Directive 93/42/EEC, ISO 13485, ISO14971, ISO10993, and GMPs 21 CFR 820 since its manufactured in the US. CE mark to be sold in EU

    Embolic coil device manufactured in the EU and sold only in the EU
    Implantable but not active, class IIa
    Medical Device Directive 93/42/EEC, ISO 13485, ISO14971, ISO10993, CE mark to be sold in EU

    Angioplasty catheter manufactured in India and sold only in India
    Class C, S 13 per Central Drugs Standard Control Organization CDSO and ISO 13485
    cdsco/medical-devices-rules-2017-classification-of-medical-devices/

    Angioplasty catheter manufactured in India and sold in the United States
    Class C, S 13 per CDSO and and GMPs 21 CFR 820 since its manufactured in the US

    Bone void filler manufactured in Europe and sold in Canada
    Class IIa Class IIb/Class III Medical Device Directive 93/42/EEC, ISO 13485, ISO14971, ISO10993 and SOR/98-282 Canadian Medical Device Regulations (CMDR) and ISO 13485
    wipo/wipolex/en/text.jsp?file_id=222650