Engineered in ISO Class 7 cleanrooms under strict EU MDR compliance. Fully validated for immediate import, tender procurement, and distribution across the Bulgarian healthcare market.
Biocompatible radiopaque silicone with Dacron cuff for secure tissue ingrowth and reduced infection rates in chronic renal care.
Complete sterile procedural tray equipped with guidewire, introducer needle, dilators, and scalpels for rapid bedside placement.
Optimized flow geometry ensuring minimal recirculation and maximum blood flow rates up to 400 mL/min during HD sessions.
Thermo-sensitive material that softens at body temperature, preventing vessel wall perforation and intimal hyperplasia.
Short-term central venous access kit designed for quick placement in acute renal failure and continuous renal replacement therapy (CRRT).
Kink-resistant, high-clarity medical tubing featuring self-sealing injection ports and standardized luer lock connectors.
Precision-sized 7Fr dual lumen catheter offering optimal flow dynamics for specialized clinical vascular access requirements.
Sterile EO validated central venous line with 2-year validated shelf life, designed for high-volume hospital tender fulfillment.
The healthcare ecosystem in Bulgaria—governed by the Ministry of Healthcare (Министерство на здравеопазването) and funded largely via the National Health Insurance Fund (НЗОК / NHIF)—is undergoing a rapid infrastructure modernization. Hospital procurement managers, private medical group networks, and regional pharmaceutical distributors across major hubs such as Sofia, Plovdiv, Varna, Burgas, and Ruse are enforcing stringent standards for single-use medical consumables.
With the mandatory transition to the EU Medical Device Regulation (EU MDR 2017/745) and oversight by the Bulgarian Executive Agency for Medicines (Българска агенция по лекарствата - BDA), healthcare institutions can no longer tolerate compliance ambiguity. Procurement contracts demand complete technical dossiers, batch-level Sterility Assurance Levels (SAL 10⁻⁶), ISO 10993 biocompatibility verification, and DEHP-free/Phthalate-free polymer formulations.
As a premier global manufacturer with over 36 years of expertise (established in 1988 under Shree Umiya Surgical Pvt. Ltd. / Mediplus India), we bridge the gap between high-tier manufacturing precision and cost-effective bulk supply. Our direct factory export pipeline empowers Bulgarian medical importers and tender contractors to secure high-margin, top-grade infusion sets, blood transfusion lines, and hemodialysis catheter kits with absolute regulatory certainty.
Technical specifications that set our infusion sets and vascular catheters apart in high-acuity clinical environments.
Our IV infusion tubing and central line lumens are extruded using 100% virgin, medical-grade polyurethane (TPU) and non-DEHP plasticized PVC. This eliminates plasticizer leaching into lipid solutions and sensitive IV medications, ensuring compliance with strict European REACH and EU MDR safety directives.
Infusion sets feature micro-drip (60 drops/mL) and macro-drip (20 drops/mL) calibrated drip chambers equipped with 15-micron fluid filters and hydrophobic bacterial air vents. Paired with micro-dial precision flow regulators (5 to 250 mL/hr), clinicians maintain consistent dosing without IV pump dependency.
Our hemodialysis catheters utilize thermo-sensitive radiopaque polyurethane. Firm during initial percutaneous insertion for accurate Seldinger-technique placement, the catheter softens at body temperature (37°C), minimizing vein wall irritation, mechanical phlebitis, and thrombus formation.
In tertiary referral centers like St. Ekaterina or Plovdiv St. George Hospital, multi-lumen central venous access and needleless infusion sets are vital. Mediplus needleless Y-site connectors and lipid-resistant 3-way stopcocks prevent needle-stick injuries and intravascular catheter-related bloodstream infections (CRBSI) during continuous TPN and vasopressor administration.
Regional hemodialysis units managing high patient turnarounds require reliable vascular access. Our long-term tunneled cuffed silicone catheters and AV fistula needles deliver high blood flow rates (>350 mL/min) with low arterial pressures, allowing smooth 4-hour dialysis cycles with minimal sheer stress on red blood cells.
Bulgarian emergency response teams require fast-priming, kink-free infusion sets that perform under rugged field conditions. Our kink-resistant PVC tubing maintains lumen integrity even when flexed tightly, while sharp spike designs allow instant insertion into standard IV solution bags.
For pediatric units requiring exact fluid management, our measured volume burette infusion sets (100mL / 150mL) with automatic shut-off floating valves prevent fluid overload and air embolism, guaranteeing micro-precision dosing for vulnerable pediatric patients.
Standardized parameters for Bulgarian tender evaluation and wholesale import verification.
| Product Family | Key Materials | Drip Rate / Size Options | Safety Features | Compliance & Sterilization |
|---|---|---|---|---|
| Standard Medical Infusion Set | DEHP-Free Medical PVC / Polypropylene | 20 drops/mL (Macro) or 60 drops/mL (Micro) | 15µm Fluid Filter, Auto Air Vent, Needleless Y-Site | CE Marked, ISO 13485, EO Sterile (SAL 10⁻⁶) |
| Measured Volume Burette Set | Rigid ABS Burette, Flexible Tubing | 100 mL / 150 mL Graduated Burette | Overfill Floating Valve, Micro Pin Spike | EU MDR 2017/745, ISO 8536-5 Compliant |
| Hemodialysis Catheter Kit (Acute) | Radiopaque Polyurethane (TPU) | 7Fr to 12Fr (Double / Triple Lumen), 13-20cm | Soft Atraumatic Tip, Rotating Suture Wings | Class III Medical Device, ISO 10993 Biocompatible |
| Tunneled HD Catheter (Permanent) | 100% Medical-Grade Silicone | 14Fr - 15Fr (Lengths: 19cm to 50cm) | Dacron Retention Cuff, Reinforced Extension Lines | CE Certified, US FDA Listed Production Lines |
| Blood Transfusion Set | High-Clarity PVC, Latex-Free Injection Flashball | 20 drops/mL with 200µm Mesh Blood Filter | Co-extruded Non-Kink Tube, Luer Lock Hub | ISO 1135-4 Standard, EO Residue < 10ppm |
Operating out of a state-of-the-art manufacturing complex in Vatva, Ahmedabad, India, Shree Umiya Surgical Pvt. Ltd. (Mediplus) maintains end-to-end control over the production lifespan. From virgin polymer compound testing to high-speed automated extrusion, cleanroom assembly, packaging, and Ethylene Oxide (EO) sterilization, nothing is outsourced.
Manufactured in ISO Class 7 & Class 8 cleanrooms with strict airborne particle, differential pressure, and microbiological monitoring.
Customized primary blister packaging, carton dimensions, localized Bulgarian labeling, multilingual IFUs, and Unique Device Identification (UDI) barcodes.
Direct FOB/CIF maritime shipping via Mundra/Nhava Sheva ports to Port of Varna / Port of Burgas, or air freight straight to Sofia Airport (SOF).
Detailed answers regarding regulatory registration, delivery timelines, minimum order quantities, and quality documentation.
Yes. Our complete product portfolio is manufactured under ISO 13485 and ISO 9001 certified quality management systems. Product families hold CE mark certification aligned with EU MDR (Regulation 2017/745), enabling smooth registration with the Bulgarian Executive Agency for Medicines (BDA - Българска агенция по лекарствата) and eligibility for NHIF (НЗОК) hospital tenders.
For standard Mediplus catalog items, MOQ starts at one pallet per SKU. For custom private-label or OEM packaging programs, MOQs typically start at a single 20-ft container mix. Lead time for production completion is 3 to 4 weeks from order confirmation and artwork approval, followed by fast sea freight (approx. 22-28 days transit to Varna/Burgas) or air express to Sofia.
Absolutely. Our dedicated export regulatory department provides full technical files, including CE Certificates, Certificates of Free Sale (CFS), ISO 13485 certificates, batch Certificates of Analysis (CoA), biological indicator sterilisation release records, and ISO 10993 biocompatibility test summaries legalized for Bulgarian customs and ministry requirements.
Sterilization is conducted in fully automated EO gas chambers in accordance with ISO 11135 standards. Each production lot undergoes bioburden testing, chemical/biological indicator verification, and gas chromatograph analysis to ensure ETO and ethylene chlorohydrin residues remain far below limits mandated by ISO 10993-7.
Yes. We specialize in OEM and private-label manufacturing. We provide fully localized outer cartons, pouch printing, unit blister artwork, instructions for use (IFU) in Bulgarian, and GS1-compliant UDI barcodes to comply with European traceability mandates.
We readily supply product evaluation sample packs for qualified medical distributors, hospital purchasing committees, and tender bidders in Bulgaria. Sample kits include physical products, technical specifications, and sterilization certificates for immediate review.
Expand your hospital supply chain, win competitive healthcare tenders in Bulgaria, and secure direct factory pricing backed by uncompromised ISO 13485 and CE MDR quality standards.
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