Medical Disposables Factory Cleanroom Assembly
B2B Global Trade Desk

Enquiry & OEM Quotation Center

Direct factory communication portal for medical device importers, regional hospital chains, Ministry of Health tender buyers, and contract manufacturing partners worldwide.

ISO 13485:2016Certified Quality Management System
70+ CountriesEstablished Export Distribution
36+ YearsMedical Manufacturing Excellence
OEM & ODMFull Private Label Support
Direct Manufacturer Engagement

Request Factory-Direct Pricing, Technical Dossiers & OEM Consultations

Since 1988, Shree Umiya Surgical Pvt. Ltd. (Mediplus India) has established itself as an authoritative manufacturer and exporter of single-use medical disposable devices. Operating advanced ISO Class 7 and Class 8 cleanrooms in Vatva, Ahmedabad, India, our engineering and export departments directly support procurement officers, hospital purchasing consortia, and international healthcare distributors across Europe, the Middle East, Africa, Latin America, and Asia.

Whether you require full container shipments of standard product lines, custom OEM configuration for private branding, or legalised regulatory dossiers for government tender submissions, our dedicated international trade desk guarantees response efficiency, complete specification accuracy, and strict compliance with global medical device regulations.

Export Procurement Process

Streamlined Purchasing & Regulatory Workflow

How our export division manages your bulk ordering, technical validation, and container shipping.

01

Inquiry Evaluation & Quote

Our trade specialists review your SKU specifications, size breakdown, annual volume forecasts, and destination port requirements to issue competitive FOB or CIF/CFR quotes within 24 hours.

02

Technical Proofing & Dossiers

We provide validated product samples, Certificates of Analysis (CoA), Technical Construction Files, and country-specific registration dossiers (FSC, ISO 13485, CE) for regulatory approval.

03

Cleanroom Manufacturing

Batch production is executed under controlled environmental conditions, accompanied by double-barrier pouch sealing, validated EO sterilisation, and full raw-material lot traceability.

04

Private Label & Packaging

Custom OEM artwork proofing, multilingual Instructions for Use (IFU), inner box layout design, and UDI/GS1 barcode mapping are executed precisely to your brand's specifications.

05

Quality Control & Release

Every shipment undergoes rigorous mechanical, physical, and bioburden testing. Final release approval includes sterilisation release certificates and complete packing list verification.

06

Port Dispatch & Logistics

Consignments are loaded into containerised units and dispatched via Mundra or Nhava Sheva ports with complete export documentation, bill of lading, and certificate of origin.

Technical Capability Overview

Quality Assurance & Compliance Standards

Engineered to satisfy stringent international medical standards and hospital tender parameters.

Cleanroom Manufacturing & Sterilisation

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Our Ahmedabad manufacturing hub is equipped with automated injection moulding, precision tube extrusion lines, and dedicated assembly bays.

  • ISO Class 7 (Class 10,000) and Class 8 (Class 100,000) certified cleanroom zones
  • Validated Ethylene Oxide (EO) sterilisation complying with EN ISO 11135 standards
  • Comprehensive EO residual level analysis and biological indicator validation per cycle
  • 100% leak testing, tensile strength testing, and flow-rate accuracy verification

Regulatory Dossiers & Global Certifications

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We support overseas distributors in obtaining national Ministry of Health (MoH) product registrations quickly and reliably.

  • ISO 13485:2016 and ISO 9001:2015 Quality Management Systems
  • CE conformity marking for high-demand clinical product families
  • Biocompatibility test summaries compliant with ISO 10993 standards
  • Provision of Free Sale Certificates (FSC), Legalized Documents, and Apostilled Dossiers
Available Product Divisions

High-Volume Disposables Ready For Export Contracting

Explore our core clinical divisions available for volume purchasing, tender supply, and contract manufacturing.

Renal Access & Dialysis

Double/Triple lumen Hemodialysis Catheters, CVC Kits, Blood Tubing Sets, Peritoneal Dialysis Sets, and AV Fistula Needles.

Infusion & Transfusion

Medical Infusion Sets, Blood Transfusion Kits, Safety IV Cannulae, Burette Sets, Stopcocks, and Extension Lines.

Urology Consumables

Siliconised Foley Balloon Catheters (2-Way/3-Way), Urine Collection Bags, Nelaton Catheters, TUR Sets, and DJ Stents.

Anaesthesia & Respiratory

Endotracheal Tubes, Tracheostomy Tubes, Venturi Masks, Guedel Airways, Suction Catheters, and Breathing Circuits.

Surgical Drainage

High-Vacuum Close Wound Suction Units, Chest Drainage Catheters, Abdominal Drain Kits, Skin Staplers, and Biopsy Needles.

Gastroenterology

Ryle's Tubes, Levin's Tubes, Infant Feeding Tubes, Stomach Tubes, Yankauer Suction Sets, and Colostomy Accessories.

General Ward Disposables

Surgical Latex Gloves, Examination Gloves, Non-Woven Caps & Masks, Mucus Extractors, and Respiratory Exercisers.

OEM Packaging Options

Pouch-to-pouch sterilisation barrier, printed inner boxes, outer master shippers, and private-label design customization.

Distributor FAQ

Frequently Asked B2B Procurement Questions

Direct responses from our export desk regarding ordering parameters, sample validation, and delivery terms.

Our dedicated export department processes all B2B trade inquiries within 24 business hours. We provide comprehensive FOB, CIF, or CFR pricing quotes along with detailed technical specifications, inner box dimensions, master carton pack sizes, and container volumetric weight data.

We assist global distributors and tender applicants by supplying full technical dossiers. This includes ISO 13485:2016 QMS certificates, CE MDR technical documentation, Certificates of Free Sale (CFS), Certificates of Analysis (CoA) per batch, ISO 10993 biocompatibility test summaries, and shelf-life stability test reports.

Standard OEM private-label programs begin at a single mixed 20-ft container or SKU-specific pallet quantities. Customization covers buyer-branded blister pouch printing, customized carton dimensions, multilingual IFU inserts, and UDI / GS1 compliant barcode labeling.

All medical disposables are produced in ISO Class 7 and Class 8 cleanrooms. Sterilisation is conducted via validated Ethylene Oxide (EO) processes complying with EN ISO 11135 standards. Each production lot is released only after physical leak testing, tensile verification, EO residue verification, and bioburden clearance.

Connect With Our International Export Desk

Contact our technical sales engineers today to receive competitive quotation pricing, request product evaluation samples, or initiate private-label OEM manufacturing discussions for your regional market.

Send an Inquiry

Products

Seven clinical ranges, 400+ single-use device SKUs.

Downloads

Catalogue, product sheets and certificate references.

Achievements

Recognitions, approvals and export milestones.

Support

Technical, regulatory and after-sales assistance.