Certificates & Accreditations

G.N DENTAL INSTRUMENTS is a Pakistan-based manufacturer of premium dental and surgical instruments, committed to meeting international quality and safety standards for medical devices. All our instruments are manufactured under strict quality control processes and comply with global regulatory requirements.

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🏅 CE Certification (EU Medical Device Regulation)

🕐 Coming Soon — We are currently in the process of obtaining CE Marking under the European Union Medical Device Regulation (EU MDR 2017/745). This certification will confirm compliance with essential health, safety, and performance requirements for medical devices sold within the European Economic Area (EEA).

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🏭 ISO 13485 – Quality Management System

ISO 13485 is the internationally recognised standard for Quality Management Systems (QMS) specific to medical device manufacturers. Compliance with ISO 13485 ensures our manufacturing processes consistently meet customer and regulatory requirements for medical devices.

• Standard: ISO 13485:2016
• Scope: Design, manufacture, and supply of dental and surgical instruments

 

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🔬 ISO 9001 – General Quality Management

ISO 9001 certification confirms our commitment to consistent quality, customer satisfaction, and continuous improvement across all business operations.

• Standard: ISO 9001:2015

 

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🇵🇰 PSQCA Compliance (Pakistan Standards)

Our instruments are manufactured in compliance with the Pakistan Standards and Quality Control Authority (PSQCA) regulations, ensuring adherence to national standards for surgical and dental instrument manufacturing in Sialkot, Pakistan — the world's leading hub for surgical instrument production.

 

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📋 Material & Safety Standards

All G.N DENTAL INSTRUMENTS products are manufactured using:

• Grade 420 & 440 Stainless Steel — corrosion-resistant, autoclavable, and biocompatible
• Non-toxic, latex-free materials compliant with international biocompatibility standards
• Autoclave-safe construction suitable for repeated sterilisation cycles

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📧 For certificate verification, bulk order compliance documentation, or regulatory enquiries, please contact us at info@gndentalshop.com

🌐 gndentalshop.com | 🇵🇰 Manufactured in Sialkot, Pakistan