ISO 13485 & CE MDR certified single-use devices manufactured under strict cleanroom conditions, tailored for contract manufacturing and institutional tenders in Nigeria.
Nigeria’s healthcare architecture is undergoing a structural transition driven by expanding tertiary healthcare facilities, increased private hospital investments, and targeted federal interventions against vascular and nephrological pathologies. Central to this growth is the constant requirement for single-use parenteral administration devices, specifically Blood Transfusion Sets, IV Infusion Sets, and Hemodialysis Access Tubing. As a leading high-volume OEM/ODM manufacturer headquartered in Ahmedabad, India, Mediplus (Shree Umiya Surgical Pvt. Ltd.) provides compliant, cost-optimized, and clinically validated medical disposables engineered specifically to withstand the operational and environmental dynamics of West Africa.
The operational environment in Nigerian health facilities demands robust packaging, thermal-stable materials, and error-free fluid delivery. Key institutional applications include:
Navigating the Nigerian medical market requires strict adherence to regulatory standardizations and financial mechanics:
Providing definitive technical parameters is vital for hospital procurement committees and biomedical engineering teams evaluating OEM contracts. Below is an engineering comparison of Mediplus single-use lines:
| Performance Metric | Blood Transfusion Set | Standard IV Infusion Set | Hemodialysis Catheter Kit |
|---|---|---|---|
| Primary Material | Medical-Grade DEHP-Free PVC / TPU | Kink-Resistant Clear PVC | Thermosensitive Implant-Grade TPU |
| Filtration Rating | 200 µm Stainless Steel / Nylon Filter | 15 µm Fluid Filter in Drip Chamber | Integrated Arterial/Venous Clamps |
| Drip Chamber Calibration | 20 Drops / mL (Standard Blood Flow) | 20 Drops/mL (Adult) or 60 Drops/mL (Pediatric) | N/A (Extracorporeal Lumen) |
| Puncture Needle / Hub | Integrated 18G/19G Ultra-Sharp Vane Needle | 21G–23G Safety IV Cannula Compatible | 18G Introducer Needle with Guidewire |
| Sterilisation Protocol | 100% Ethylene Oxide (EO) Gas (ISO 11135) | Ethylene Oxide (EO) / Gamma Available | EO Sterilized with Biological Release |
| Pressure Tolerances | Withstands up to 2.0 bar gravity press | Standard gravity / infusion pump pressure | High-pressure rated up to 300 psi |
| Compliance Standards | ISO 1135-4, CE MDR, NAFDAC Approved | ISO 8536-4, CE MDR, ISO 13485 | ISO 10555-1/-5, CE Class III |
Established in 1988 in Vatva, Ahmedabad, Shree Umiya Surgical Pvt. Ltd. (Mediplus) has built over 36 years of expertise manufacturing medical single-use devices. For Nigerian pharmaceutical distributors, hospital chains, and federal tender contractors, our facility offers unmatched vertical integration and manufacturing independence.
We perform raw material compounding, injection molding, tube extrusion, cleanroom manual/automated assembly, and primary packaging completely in-house. This eliminates third-party sub-assembly defects and guarantees absolute batch-to-batch consistency.
Nigerian brand owners can leverage our OEM service. We provide customized primary blister packaging, inner carton design, multilingual Instructions for Use (IFU), and Unique Device Identification (UDI) barcoding registered under your brand identity.
Our dedicated regulatory department prepares full technical documentation including Certificates of Free Sale (FSC), ISO 13485:2016 certificates, CE declaration of conformity, ISO 10993 biocompatibility summaries, and EO residue validation for rapid NAFDAC approval.
Addressing critical procurement, regulatory, and logistics queries for medical device importers in Lagos, Abuja, Port Harcourt, and Kano.
We provide full regulatory support for NAFDAC submissions. This includes legalised Certificates of Free Sale (FSC), ISO 13485:2016 Quality Management System certificates, CE MDR Mark certificates, plant master files, batch manufacturing records, bioburden test reports, and 5-year accelerated stability data dossiers certified by notified bodies.
Our blood transfusion sets utilize medical-grade, non-DEHP plasticized PVC or Thermoplastic Elastomers engineered to remain flexible without leeching under high ambient humidity and heat. The 200-micron nylon mesh filter features controlled pore geometry that maintains smooth blood cell passage while capturing micro-aggregates and fibrin threads.
For standard catalogue items, MOQs start at one pallet per SKU. For custom OEM private-label programs (customized box branding, specified tubing lengths, and targeted component configs), initial orders start at a single mixed 20-foot container load. Standard manufacturing lead time is 3 to 4 weeks from artwork approval.
Yes. We specialize in consolidated container logistics. Nigerian distributors can combine IV Infusion Sets, Blood Transfusion Sets, Hemodialysis Catheter Kits, Foley Catheters, and Surgical Disposables into a single 20ft or 40ft HQ container to optimize freight efficiency and reduce landed cost per unit at Apapa, Tin Can, or Onne ports.
Sterilization cycles are conducted in strict accordance with ISO 11135 standards. Every batch is released against biological indicators (Bacillus atrophaeus) and chemical indicators. Gas chromatography testing guarantees residual Ethylene Oxide (EO) and Ethylene Chlorohydrin (ECH) levels remain well below the limits mandated by European and international pharmacopeias (<10 ppm).
We offer flexible commercial arrangements to support Nigerian buyers. We support Irrevocable Letters of Credit (LC at Sight) from reputable international banks, as well as Telegraphic Transfer (TT) structures. Shipments can be arranged under FOB (Mundra / Nhava Sheva port), CFR, or CIF Lagos/Port Harcourt terms.
Yes. We supply sterile evaluation sample kits to qualified distributors, institutional buyers, and biomedical evaluation boards. Samples come complete with Certificates of Analysis (CoA) and product technical specification sheets to facilitate hospital committee approval.
Expand your medical portfolio in Nigeria with high-margin, clinically proven blood transfusion sets, infusion lines, and hemodialysis devices. Contact our dedicated export team today for factory-direct quotes, technical specifications, and OEM sample requests.
