ISO 9001 & ISO 13485 Certified WHO-GMP CE Marked Manufacturing in India since 1955
Sterimed Group corporate headquarters and manufacturing infrastructure
Company Profile

About Sterimed Group

A trusted global manufacturer of single-use medical devices, surgical disposables, and silicone technology since 1955.

Our Legacy & Expertise

70 Years of Precision Engineering in Medical Disposables

Founded in 1955, Sterimed Group has grown into one of Asia's most comprehensive medical device manufacturers. Over nearly seven decades of continuous technical evolution, we have established state-of-the-art cleanroom manufacturing facilities in India, specializing in high-volume, precision-molded medical disposables.

We operate fully automated polymer extrusion, silicone moulding, automated dipping, adhesive coating, and EO terminal sterilization lines. Our product engineering teams collaborate directly with international healthcare buyers, regulatory bodies, and clinical experts to ensure seamless performance, safety, and patient comfort at the bedside.

Sterimed cleanroom manufacturing for medical disposables
1955 Established Leadership
90+ Global Export Markets
100+ ISO/CE Certified SKUs
100% Lot Traceability
Quality Infrastructure

Uncompromising Quality Control for Overseas Procurement

Sterimed Group provides global distributors and healthcare systems with fully compliant technical dossiers, batch testing, and certified sterilization standards required for seamless customs clearance and hospital tenders.

ISO 13485 & WHO-GMP Certified

Our Quality Management System operates under stringent ISO 13485:2016 standards and WHO-GMP guidelines, enforcing strict environmental particle monitoring and microbial controls across controlled cleanrooms.

Validated EO Sterilization (ISO 11135)

Terminal sterilization is conducted in-house using computerized Ethylene Oxide chambers validated per ISO 11135 parameters. Every batch is released with complete biological indicator reports and residual analysis.

Biocompatibility & Raw Material Integrity

All raw materials—including medical-grade PVC, liquid silicone rubber, and latex—undergo thorough screening for cytotoxicity, sensitization, and irritation per ISO 10993 testing standards.

OEM & Private Label Customization

We provide full-spectrum OEM and private-label solutions for international brands, offering multilingual packaging, customized IFUs, brand printing, and tailored shipping configurations.

Production Capabilities

End-to-End Medical Device Solutions

Our integrated manufacturing plants cover 10 core clinical disciplines, delivering consistent quality and reliable lead times for high-volume international orders.

Urology & Continence Care

High-volume production of 2-way/3-way Foley balloon catheters, pediatric catheters, silicone-coated urology lines, and closed urine drainage systems engineered for smooth insertion and inflation symmetry.

Airway Management & Critical Care

Siliconised endotracheal tubes, cuffed/uncuffed ET tubes, tracheostomy tubes, and closed suction systems designed with high-volume low-pressure cuffs to minimize tracheal trauma during ICU ventilation.

Wound Care & Surgical Tapes

Advanced acrylic and silicone gel adhesive coating technology delivering breathable microporous tapes, elastic adhesive bandages, and hypoallergenic surgical dressings for sensitive skin.

Precision Silicone Tubing & Extrusion

Through our specialized division (Ultrasil), we produce platinum-cured silicone tubing, reinforced pressure hoses, and pharmaceutical-grade silicone gaskets for bioprocessing and medical equipment.

Partner with India’s Trusted Medical Device Exporter

Looking for reliable bulk supply, competitive factory-direct pricing, or custom OEM manufacturing? Contact our global export team today to receive product catalogues and quotation details.

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