Medono India

ISO Certification

Medono India is ISO 13485:2016 certified by UK Certification & Inspection Ltd., confirming compliance with international quality management standards for medical devices.
This certification covers the manufacturing and supply of Hair Transplant Instruments, Dermatology and Medical Equipment, Medical Furniture and related medical products. The quality management system ensures strict process control, risk management, product traceability and continuous improvement in accordance with global regulatory requirements.
Certificate Number: UQ-2023040804 Date of Certification: 8th April 2023 Certificate Valid Till: 7th April 2026
The validity of this certificate can be verified at:www.ukcertifications.org.uk/verify

Quality Certificates

Medono India is CE Certified for Medical Devices in accordance with the European Council Directive 93/42/EEC as amended by 2007/47/EC (Class I).
This certification confirms that the technical files and quality system for our products comply with applicable European safety, quality and regulatory requirements. The certification covers a wide range of products including Hair Transplant Equipment, Dermatology and Medical Equipment, Ophthalmology Products, General Surgery Instruments, Medical Furniture, Hospital Equipment and related medical devices.
Manufacturer: Medono India Certificate Number: CE-4096 Date of Certification: 17th March 2023 Certificate Valid Till: 16th March 2026
The validity of this CE certificate can be verified at:www.ukcertifications.org.uk/verify

Our Certifications

Medono India is registered and compliant with U.S. FDA regulatory guidelines for medical and scientific instruments. This certification confirms that our quality management system and listed products conform to applicable U.S. FDA requirements.
The U.S. FDA registration covers a wide range of products including Hair Transplant Instruments, Dermatology and Medical Equipment, Ophthalmology Products, General Surgery Instruments, Medical Furniture, Hospital Equipment and Disposable Medical Products.
Manufacturer: Medono India Certificate Number: UG/23M04180 Date of Initial Registration: 23rd December 2023 Re-Certification Due: 22nd December 2026
The validity of this certificate can be verified at:www.mqacertification.com

Certificate of Registration

Medono India is registered with the Central Drugs Standard Control Organization (CDSCO), Government of India, under Form MD-42 in accordance with the Medical Devices Rules, 2017.
This registration authorizes Medono India to sell, stock, exhibit, offer for sale and distribute medical devices, including in-vitro diagnostic medical devices, in compliance with Indian regulatory requirements.
Registration Number: RMD/DCD/23/20-5427/1068 Date of Issue: 25th August 2023 Issued By: State Licensing Authority, Drugs Control Department, Govt. of NCT of Delhi
The CDSCO registration confirms our adherence to statutory regulations, safety norms and quality standards applicable to medical devices in India.

IEC Certificates

Medono India is registered with the Directorate General of Foreign Trade (DGFT), Ministry of Commerce & Industry, Government of India, and holds a valid Importer–Exporter Code (IEC).
This IEC registration authorizes Medono India to legally import and export medical devices, Hair Transplant Instruments, Dermatology and Medical Equipment, Medical Furniture and Disposable Medical Consumable Products in compliance with Indian foreign trade regulations.
IEC Number: G V S P K 9 5 3 4 A Date of Issue: 13th October 2021 Issued By: DGFT, Government of India
The authenticity and validity of this IEC can be verified on the official DGFT website at:https://dgft.gov.in