Fairmount Industries Pvt Ltd

Fairmount Industries Pvt Ltd specialises in surgical instruments, including haemostatic forceps (13 cm, stainless steel), ENT (ear, nose, and throat) tools, retractors, and precision scissors like universal scissors (14 cm) and Metzenaum scissors (14 cm, CVD-coated, T.C. blades). Their product range also includes a kidney tray (German pattern, 150 mm, stainless steel) designed for surgical procedures. These devices are primarily made from stainless steel, with some featuring specialised coatings.

Fairmount Industries Pvt Ltd is headquartered in Pakistan. The company’s location influences its regulatory compliance requirements, particularly for devices intended for markets like the European Union, where classification and listing standards apply.

Fairmount Industries Pvt Ltd’s devices are listed in the EUDAMED database, which is the European Union’s medical device registry. This listing is relevant for devices classified under the EU Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR), ensuring traceability and compliance for market placement in the EU.

Fairmount Industries Pvt Ltd’s devices fall under Class I classification in the EU regulatory framework. This classification applies to low-risk devices like many surgical instruments, including forceps, scissors, and retractors, which typically require less stringent pre-market evaluation compared to higher-risk categories. Classification is determined by factors like intended use, duration of contact with the body, and potential risks.