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: SIMAP Membership
Certificate No: B329
Range: Membership with Surgical Instruments Manufacturers Association of Pakistan
Reference: Blue Icon is a registered member of SIMAP, representing the surgical manufacturing sector of Sialkot. Membership affirms our industry presence and professional commitment.
Name: Free Sale Certificate
Certificate No: 180
Range: Reusable & Disposable Surgical, Dental, Electro Surgical, Orthopedic, and Beauty Instruments
Reference: Issued by the Office of District Health Officer Sialkot, this certificate confirms that Blue Icon is authorized to freely manufacture and export medical instruments in Pakistan and abroad, especially to the US, UK, Canada, Europe, and Vietnam.
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