ISO 9001 & ISO 13485 Certified WHO-GMP CE Marked Manufacturing in India since 1955
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1955Manufacturing Heritage
90+Export Markets Worldwide
ISO 13485Certified Medical Quality QMS
100%Ethylene Oxide (EO) Sterility
Precision Engineering for Maternal & Child Health

Global Standard Gynaecological & Paediatric Surgical Disposables

Sterimed Group combines over six decades of medical device manufacturing experience with cutting-edge polymer engineering to produce high-precision maternal, obstetric, and neonatal disposables. Designed to meet the stringent clinical safety demands of obstetricians, neonatologists, and critical care units worldwide, our products prioritize patient safety, tissue preservation, and sterile barrier integrity.

Manufactured in state-of-the-art cleanroom environments under strict ISO 13485 and WHO-GMP compliance, every device undergoes rigorous quality checks, biocompatibility validation (ISO 10993 standard), and Ethylene Oxide (EO) sterilisation to ensure tender compliance for healthcare buyers in Europe, Latin America, Africa, the Middle East, and Asia.

  • 100% Biocompatible, Medical-Grade & DEHP-Free Raw Materials.
  • Validated Ethylene Oxide (EO) Sterilisation with Full Batch Traceability.
  • Atraumatic Smooth-Finished Designs to Protect Delicate Mucosal Tissue.
  • Comprehensive OEM, Private Label & Custom Sterile Packaging Options.
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Sterimed Gynaecology and Paediatric Disposables Range
ISO 13485CE Marked & WHO-GMP
Complete Catalogue

Gynaecology & Paediatric Product Lineup

Browse our specialized range of obstetric instruments, cervical dilation balloon catheters, postpartum haemorrhage control systems, and neonatal disposables.

Obstetrics Sterimed Denniston Double-End Cervical Dilators

Sterimed Denniston Double-End Cervical Dilators

Engineered for smooth, gradual cervical dilation in gynaecological and surgical procedures. Features dual-ended atraumatic tapered tips, high structural stability, and a polished surface finish to minimize cervical tissue trauma during insertion.

Labor Induction Cervi-Cath Cervical Ripening Balloon Catheter

Cervi-Cath (Cervical Ripening Balloon Catheter)

A safe, drug-free mechanical cervical ripening catheter designed for labor induction. The dual-balloon mechanism exerts uniform pressure on both internal and external cervical os, facilitating natural cervical softening and effacement.

PPH Control Haemolock Uterine Balloon Tamponade

Haemolock – Uterine Balloon Tamponade

Critical care medical device designed for the emergency management of Postpartum Haemorrhage (PPH). Provides immediate hydrostatic intrauterine pressure to control uterine bleeding effectively, reducing the need for invasive surgical interventions.

Gynaecology Manual Vacuum Aspiration MVA Kit

Manual Vacuum Aspiration (MVA Kit)

Complete single-use uterine evacuation kit including an ergonomic double-valve aspirator syringe and flexible, color-coded adaptors and cannulae. Delivers reliable, controlled suction for clinical intrauterine procedures.

Diagnostics Cytobrush Endocervical Brush

Cytobrush / Endocervical Brush

Precision endocervical sampling device featuring soft, flexible bristles designed to collect rich cellular samples for Pap smear screening and cervical cytology diagnostics without patient discomfort.

Neonatal Care Infant Mucus Extractor

Infant Mucus Extractor

Sterile aspiration device designed for clearing newborn neonatal airways. Features a transparent graduated container, extra lid for hygienic sample transport, and soft atraumatic suction tube with a hydrophobic filter.

Neonatal Care Umbilical Cord Clamp

Umbilical Cord Clamp

Sterile medical-grade polymer umbilical clamp equipped with a dual-action security lock to prevent accidental opening and non-slip finger grooves for firm, safe clamping of the newborn umbilical cord.

Paediatric Umbilical Catheter

Umbilical Catheter

Radiopaque vascular catheter manufactured from smooth, biocompatible polymer for umbilical vein or artery access in neonates. Features accurate depth markings and a rounded open-end tip for atraumatic insertion.

Maternity Sterile Delivery Kits for Childbirth

Delivery Kits – Safe Childbirth Solutions

Comprehensive, customizable sterile delivery packs for normal and caesarean childbirth. Includes sterile drapes, surgical gowns, umbilical cord clamps, baby wraps, and absorbent pads to maintain sterile field integrity.

Manufacturing Compliance

Built for Global Hospital Tenders & Regulatory Submissions

Sterimed Group provides complete documentation and technical dossiers required by international health authorities, ministries of health, and commercial medical procurement channels. Our Gynaecology and Paediatric product portfolio is manufactured under stringent quality control protocols at every stage of production.

From raw material chemical analysis to batch-wise sterility testing certificates, we ensure seamless customs clearance and tender readiness for overseas distributors.

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ISO 13485 QMS

Device-specific quality management system covering design controls, risk analysis, and manufacturing execution.

CE Certification

Full technical documentation compliant with European CE regulatory requirements for medical disposables.

EO Sterilisation

Validated Ethylene Oxide sterilisation cycles monitored with chemical and biological indicators per ISO 11135.

Biocompatible Materials

Non-toxic, DEHP-free, and medical-grade polymers tested according to ISO 10993 biological evaluation standard.

Atraumatic Design

Precision-molded surfaces and polished edges to safeguard sensitive cervical and neonatal anatomical structures.

OEM & Custom Kits

Flexible packaging options, private label artwork, and custom sterile delivery pack assembly for distributors.

Technical Reference

Gynaecology & Paediatric Product Specifications Matrix

Quick technical overview for hospital procurement committees and international distribution partners.

Product Name Available Sizes / Specs Material Grade Sterilisation Method Packaging
Denniston Cervical Dilators Double-Ended (Multiple mm sizes) Medical-Grade Stainless Steel / Polymer Sterile / Autoclavable Individual Sterile Pouch
Cervi-Cath Balloon Catheter 18 Fr / Dual Balloon (30ml-80ml) 100% Medical Grade Silicone EO Sterilised Sterile Peelable Pouch
Haemolock Uterine Tamponade 24 Fr / 500ml Max Balloon Capacity Biocompatible Silicone with Rapid Fill Line EO Sterilised Sterile Kit Pouch with Spike & Valves
MVA Kit (Manual Vacuum Aspiration) 60ml Aspirator + Cannulae (4mm–12mm) Medical Grade Polypropylene & Flexible Cannulae EO Sterilised Complete Procedure Sterile Pack
Infant Mucus Extractor 25ml Capacity Container with Filter Clear DEHP-Free PVC with Hydrophobic Filter EO Sterilised Individual Sterile Pouch
Umbilical Catheter Fr. 3.5, 4.0, 5.0, 6.0, 8.0 Radiopaque Medical Grade Polyurethane / PVC EO Sterilised Sterile Hard Blister Pack
Patient Delivery Kits Normal & Caesarean Delivery Configurations Non-Woven SMS Fabrics & Disposable Tools EO Sterilised Heavy Duty Sterile Medical Bag
Buyer Questions

Gynaecology & Paediatrics Disposables FAQ

Sterimed manufacturing facilities operate under ISO 9001 and ISO 13485 Quality Management Systems. Our gynaecology and paediatric medical devices comply with WHO-GMP requirements and hold CE marking, supported by complete technical dossiers for international registration.

Yes. All devices, including umbilical catheters, cervical dilators, and infant mucus extractors, feature atraumatic smooth surfaces, rounded tip geometry, and non-toxic DEHP-free biocompatible materials evaluated according to ISO 10993 standards.

Yes. We support full OEM and private-label programs. International buyers and distributors can customize component selection for delivery kits, brand labeling, language-specific IFUs, and sterile pouch packaging formats.

Single-use products are terminally sterilised using Ethylene Oxide (EO) under validated cycles per ISO 11135 guidelines. They maintain a standard shelf life of 5 years when kept in unopened sterile packaging.

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Partner with an established Indian manufacturer of Gynaecology and Paediatric medical disposables supplying 90+ countries.