OUR CERTIFICATES

Name: ISO 13485 Audit (Notify Body no. 2435)
Certificate No: 3D6DE51CBC2
Range: Quality Management System for Medical Devices
Reference: Blue Icon’s QMS complies with EN ISO 13485:2016, ensuring the highest standards in manufacturing and exporting surgical & dental instruments

Name: CE Marked
Certificate No: PK-MF-000046870
Range: Compliance with EU MDR 2017/745 for Class I Medical Devices
Reference: Yousfis S.L. is the EU Authorized Representative for Blue Icon. CE marking is permitted upon regulatory compliance. Valid until the EC REP agreement expires or changes occur.

Name: Sialkot Chamber of Commerce & Industry
Certificate No: Serial No. 1703241, Membership No. A-68830
Range: Affiliated with Federation of Pakistan Chambers of Commerce & Industry Karachi
Reference: Blue Icon

Name: Surgical Instrument Manufacturers Associatons of pakistan
Certificate No:
Range:
Reference:

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