Gold Standard in Medical Equipment Manufacturing & Supply

Welcome to IndoSurgicals Private Limited, your trusted partner in the medical equipment industry. As a leading manufacturer and supplier, we are committed to delivering high-quality products that meet all statutory and regulatory requirements. With our range of certifications, approvals, and licenses, including ISO 9001, ISO 13485, CE Certification, GMP Certificate, CDSCO License, BARC Approval for our radiation protection apparels, and Model Approvals for our Height and Weight measurement devices like Stadiometer and Infantometer from Legal Metrology (Ministry of Consumer Affairs, Government of India), we ensure the utmost quality and compliance.

 

ISO 9001 Certificate: Our ISO 9001 certification demonstrates our dedication to implementing and maintaining a robust quality management system. This certification validates our commitment to delivering products and services that consistently meet customer requirements and regulatory standards.

 

ISO 13485 Certificate: IndoSurgicals holds an ISO 13485 certification, an internationally recognized standard for medical device quality management systems. This certification affirms our adherence to the highest quality standards throughout the design, development, production, and distribution of medical devices.

 

CE Certification: Our products bear the CE mark, indicating compliance with the essential requirements of the European Union's Medical Devices Directive. This certification demonstrates our commitment to meeting European quality and safety standards, allowing us to provide our products to customers across the European market.

 

GMP Certificate: IndoSurgicals adheres to Good Manufacturing Practices (GMP) to ensure the consistent production of safe and effective medical devices. Our GMP certification underscores our strict adherence to quality control measures, traceability of materials, and standardized production processes.

 

CDSCO License: We hold a valid license from the Central Drugs Standard Control Organization (CDSCO), which regulates the import, manufacture, and sale of medical devices in India. This license ensures that our products comply with the necessary regulatory requirements and undergo rigorous evaluation to guarantee their safety and efficacy.

 

BARC Approval for Radiation Protection Apparels: Our radiation protection apparels have been approved by the Bhabha Atomic Research Centre (BARC), a premier nuclear research facility in India. This endorsement signifies that our products effectively safeguard healthcare professionals and patients from the potential hazards of ionizing radiation.

 

Model Approvals for Height and Weight Measurement Devices: Our Stadiometer and Infantometer have received Model Approvals from the Legal Metrology department, under the Ministry of Consumer Affairs, Government of India. These approvals ensure that our measurement devices adhere to the highest accuracy standards and provide reliable measurements for medical professionals and patients.

 

At IndoSurgicals Private Limited, we take immense pride in our commitment to quality, compliance, and customer satisfaction. With our extensive range of certifications, approvals, and licenses, we assure you that our products meet the highest industry standards. Choose IndoSurgicals as your trusted partner for all your medical equipment needs, and experience the excellence and reliability that sets us apart.

 

IndoSurgicals CE Certificate IndoSurgicals ISO Certificate IndoSurgicals GMP Certificate