FDA, ISO & CE Certified Surgical Instruments | Ameri SI - Ameri Surgical Instruments Inc.

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Committed to Quality & Compliance
At Ameri Surgical Instruments, we are dedicated to upholding the highest standards of safety, quality, and regulatory compliance. Our certifications reflect our commitment to manufacturing precision surgical instruments that meet global healthcare standards.

Our Certifications

1. FDA Registration (FDA Registration Database)

  • FDA Registration Number: 10086043

  • Scope: Registered with the U.S. Food and Drug Administration (FDA) for the manufacture and distribution of surgical instruments.

  • Compliance: Ensures our instruments meet strict safety and performance standards required for medical use in the United States.

FDA Approved Surgical Instruments

2. ISO Certifications (ISO Certification Info)

  • ISO 9001:2015 – Quality Management System

    • Certified for maintaining a systematic approach to quality management, ensuring customer satisfaction and continuous improvement.

Ameri Surgical Instruments Inc. ISO 9001:2015 Certification, demonstrating adherence to international quality management system standards for surgical instrument manufacturing.

  • ISO 13485:2016 – Medical Devices Quality Management System

    • Specifically designed for medical device manufacturers, this certification ensures that our surgical instruments meet regulatory requirements and international safety standards.

Ameri Surgical Instruments Inc. ISO 13485:2016 Certification, confirming compliance with medical device industry regulations for consistent quality and safety.

3. CE Certification – Class I Medical Devices

  • Certificate No.: USSOCS/71129674

  • Issued By: USSOCS Certification Services

  • Scope: Covers reusable surgical, dental, holloware, veterinary, orthopedic, manicure, pedicure instruments, and all kinds of scissors.

  • Compliance: Certified under Council Directive 93/42/EEC, as updated by Directive 2007/47EEC, ensuring conformity with European health, safety, and environmental protection standards.

  • Validity: March 21, 2025 – March 20, 2028

Ameri Surgical Instruments Inc. CE Certificate (Certificate No. USSOCS/71129674), authorizing the sale of Class I medical devices in European markets under the Medical Device Directive 93/42/EEC.

Why Our Certifications Matter

Our compliance with FDA, ISO, and CE standards ensures that:
✅ Our surgical instruments meet international safety and performance requirements.
✅ We follow rigorous quality control and manufacturing practices.
✅ Our customers receive durable, high-precision, and reliable medical devices.

For more details or to request certification documents, please contact us at:
📧 info@amerisurgicalinstruments.com
📞 +1 (513) 878-5772