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Transfusion Set Manufacturer & Exporter Serving Portugal

EU MDR Compliant, ISO 13485 Certified Blood Administration Systems, Micro-Drip Burette Sets, and Precision Infusion Lines Engineered for Portugal's SNS Hospitals and Private Healthcare Networks.

Featured Blood Transfusion & Infusion Consumables

Exceeding European Pharmacopoeia and ISO 1135-4 standards, our single-use medical devices are engineered for optimal flow control, haemolysis prevention, and zero-leakage security across clinical blood transfusions in Portugal.

Disposable Latex Free Customized TPE Medical Tourniquet
Disposable Latex-Free TPE Medical Tourniquet
Material: TPE Elastomer Non-Sterile / Clean Pack
High-elasticity, latex-free phlebotomy tourniquet designed to eliminate cross-contamination risk and skin allergies during blood sampling and transfusion priming procedures in clinical wards.
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Four Way Connector Injection Mold Plastic Pipe Fittings IV Syringe Infusion Set
Straight 4-Way Connector IV Infusion Lines
Fitting: Luer Lock / Slip EO Sterilized
Precision injection-molded 4-way manifold fittings engineered for multi-channel intravenous therapy. Features high tensile strength, leak-proof pressure resistance, and crack-free polymer formulation.
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Disposable Blood Transfusion Set with Leukocyte Filter
Blood Transfusion Set with Leukocyte Filter
Filter Pore: 20–40 μm Pyrogen-Free
Advanced blood administration set equipped with a micro-aggregate leukocyte depletion filter. Prevents non-haemolytic febrile transfusion reactions (NHFTR) during packed red blood cell (PRBC) delivery.
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Medical Single Use IV Blood Transfusion Set EO Sterilized
Standard Single-Use IV Blood Transfusion Set
Standard: 20 Drops/mL Standard Filter: 170-200 μm
Class-leading gravity blood transfusion line featuring a sharp ABS spike, flexible cylindrical drip chamber with 200μm blood filter grid, smooth roller clamp, and kink-resistant PVC tubing.
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ABS Transfusion Set With Vented Spike for 3.0mm ID Tubing
Vented ABS Spike Transfusion Set (3.0mm ID Tubing)
Spike Type: Vented Air Inlet Tubing: 3.0mm x 4.1mm
High-flow transfusion line designed with an integrated hydrophobic air-vent filter for glass bottle and rigid container administration. Maintains constant flow rates without vacuum collapse.
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Disposable Infusion Transfusion Set with Burette Soluset
Burette Transfusion & Infusion Set (Soluset)
Capacity: 100ml / 150ml Drip: 60 Drops/mL
Volumetric measured-chamber infusion set with floating shut-off valve, micro-drip orifice, and injection site. Ensures pinpoint fluid and blood component volume control for critical interventions.
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Medical Transfusion Set Burette Intravenous Disposable Infusion Set With Filter
Pediatric & ICU Burette Intravenous Transfusion Set
Safety: Automatic Shut-off Port: Latex-Free Y-Site
Designed for delicate transfusion regimens requiring exact dosage measurement. Includes a 150ml clear graduated cylinder, 170-micron filter mesh, and needle-free or Y-injection port options.
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Pediatric IV Infusion Set With Burette Transfusion Systems
Pediatric Micro-Drip Transfusion & Infusion System
Needle: 21G - 23G Included DEHP-Free Plasticizer
Ultra-precise pediatric blood administration set engineered with soft biocompatible tubing, micro-pin drip nozzle (60 drops = 1 mL), and overload protection valve for pediatric oncology and NICU applications.
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30+
Years Manufacturing Experience
52+
Global Export Markets
Class 10,000
ISO 7 Clean Room Production
100%
EU MDR & ISO 13485 Compliant

Technical White Paper: Elevating Transfusion Safety in Portugal's Healthcare Ecosystem

Blood transfusion therapy represents one of the most critical interventions in modern clinical medicine. Across Portugal's comprehensive health infrastructure—encompassing the public national health service (SNS - Serviço Nacional de Saúde), specialized blood agencies such as the Instituto Português do Sangue e da Transplantação (IPST), and prominent private hospital networks like CUF, Luz Saúde, and Joaquim Chaves Saúde—the demand for high-integrity, single-use blood administration equipment has reached unprecedented levels. As medical technology advances, hospital procurement teams and medical device distributors must navigate stringent regulatory requirements, specifically the transition from the Medical Device Directive (MDD 93/42/EEC) to the comprehensive European Union Medical Device Regulation (EU MDR 2017/745).

As an ISO 13485 certified manufacturer established in 1994, Angiplast Pvt. Ltd. delivers technical excellence and manufacturing reliability directly aligned with Western European clinical expectations. Our single-use transfusion sets are crafted using advanced medical-grade polymers, continuous automated assembly within monitored Class 10,000 cleanrooms, and rigorous lot-level ethylene oxide (ETO) sterilisation cycles. By incorporating precise drop-forming nozzles, non-haemolytic micro-mesh filtration (170–200μm standard grids and 20–40μm leukocyte micro-aggregate filters), and phthalate-free/DEHP-free formulation capabilities, our transfusion products mitigate clinical risks such as air embolism, blood clot dissemination, bacterial contamination, and phlebitis.

Haemovigilance and Material Biocompatibility

Modern haemovigilance protocols enforced by Portugal's National Authority of Medicines and Health Products (INFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde) require uncompromising physical and biological safety standards for blood contact components. When whole blood, packed red blood cells (PRBC), fresh frozen plasma (FFP), or platelet concentrates pass through a delivery line, the inner surface of the plasticized tubing must exhibit neutral shear stress characteristics to prevent mechanical haemolysis.

Angiplast’s manufacturing protocols utilize top-tier, virgin non-toxic PVC modified with advanced non-DEHP plasticizers (such as TOTM or DINCH) or medical TPE elastomers. This prevents endocrine-disrupting chemicals from leaching into the patient’s bloodstream during prolonged transfusion routines—a vital consideration for neonatal, pediatric, and chronic transfusion therapy patients across Portuguese hospitals.

Angiplast Clean Room Medical Disposable Manufacturing Facility

Localized Application Scenarios in Portuguese Clinical Practice

SNS Public University Hospitals

Major hospital centers such as Centro Hospitalar Universitário de Lisboa Norte (CHULN), Centro Hospitalar Universitário de São João (CHUSJ Porto), and CHUC Coimbra require massive volumes of standardized, high-reliability transfusion sets for emergency departments, trauma operating theaters, and organ transplant units. Our vented ABS spike transfusion sets with high flow-rate 3.0mm inner diameter tubing ensure rapid blood delivery during acute haemorrhage resuscitation.

IPST & Regional Blood Banks

The Instituto Português do Sangue e da Transplantação oversees national blood donation collections, component separation, and distribution across Lisbon, Porto, and Coimbra. Our specialized blood administration sets featuring 20–40μm leukocyte filtration media and blood collection accessories support seamless handling from blood collection bags to bed-side administration, protecting cellular integrity throughout processing.

Private Healthcare Networks

Private medical facilities like Hospital CUF Descobertas, Hospital da Luz Lisboa, and Joaquim Chaves clinics emphasize patient comfort, rapid turnaround, and zero infection rates. Angiplast supplies needle-free transfusion extension sets and latex-free TPE tourniquets that minimize venous trauma, avoid accidental needle-stick injuries to nursing staff, and lower post-operative phlebitis risks.

Pediatric & NICU Departments

In neonatal intensive care units, precise fluid dosing is paramount to avoid circulatory overload. Our pediatric burette sets (Soluset 100ml/150ml) incorporate calibrated micro-drip chambers (60 drops/mL), automatic shut-off floating valves, and fine roller clamps, empowering clinicians in Lisbon and Porto to deliver micro-volumetric transfusions with total confidence.

Regulatory Compliance & Market Trends in Portugal

Portuguese healthcare tenders demand complete regulatory transparency and strict adherence to European medical safety mandates. Importers, tender bidders, and hospital procurement officers in Portugal must evaluate several key regulatory criteria when selecting international medical device manufacturing partners:

  • EU MDR 2017/745 Certification: Full transition from older MDD directives to MDR technical documentation, including rigorous Clinical Evaluation Reports (CER), Post-Market Surveillance (PMS), and Unique Device Identification (UDI) barcoding for 100% supply chain traceability.
  • INFARMED Registration Readiness: Before medical devices can be commercialized in Portugal, they must be registered in the INFARMED database (National System of Medical Devices). Angiplast provides comprehensive technical dossiers, Free Sale Certificates (FSC), ISO 13485:2016 certificates, and CE Certificates of Conformity to streamline importer registration.
  • Phthalate-Free & Latex-Free Directives: In compliance with European REACH regulations and medical device safety updates, Portuguese hospitals actively prioritize DEHP-free PVC and 100% latex-free construction to safeguard vulnerable patient populations against toxicological risks.
  • Green Hospital Procurement & Waste Reduction: European sustainability goals are driving demand for optimized packaging, recyclable pouch materials, and reduced plastic volume without compromising sterile barrier integrity (ISO 11607 compliant packaging).

Technical Specification Matrix: Transfusion Set Configurations

The following comparative matrix outlines key engineering parameters across our primary blood transfusion and administration product lines designed for hospital distribution across Portugal.

Product Model / Configuration Drip Chamber & Filter Mesh Tubing Diameter & Material Spike Design Patient Connector Primary Clinical Application
Standard Gravity Transfusion Set Cylindrical Chamber w/ 170-200μm Filter 3.0mm ID / 4.1mm OD Medical PVC Non-Vented ABS Piercing Spike Rotating Luer Lock w/ Cap General Ward & Surgical Blood Transfusions
Vented Air-Inlet Transfusion Set Soft Chamber w/ 200μm Filter Grid 3.0mm ID Kink-Resistant PVC Vented ABS Spike w/ Hydrophobic Filter Fixed / Rotating Luer Lock Rigid Bottle & Glass Container Transfusions
Leukocyte Filter Transfusion Set Dual-Chamber w/ 20-40μm Micro-Filter High-Flexibility DEHP-Free PVC Sharp Integrated Plastic Spike Luer Lock with Injection Y-Site Oncology, Dialysis & Leukoreduced PRBC Transfusions
Pediatric Volumetric Burette Set 100ml / 150ml Calibrated Chamber (60 drops/ml) Microbore Precision Tubing Vented Spike with Hanging Ring Needle-Free Valved Injection Port NICU, PICU & Micro-Dose Blood Administration
Multi-Way Infusion Manifold Line Injection Molded 4-Way Flow Manifold Pressure-Rated TPE / PVC Lines Male / Female Luer Lock Fittings Multiple Self-Sealing Ports ICU Multi-Drug & Blood Component Co-Administration
Angiplast OEM and Contract Manufacturing Infrastructure

Why Portuguese Distributors Partner with Angiplast

Angiplast Private Limited stands as a premier global OEM and CDMO medical device manufacturer headquartered in Ahmedabad, India. With over 30 years of manufacturing mastery, our facility operates in strict alignment with international quality management standards.

  • In-House Controlled Environment: Precision injection molding, extrusion, assembly, and ETO sterilisation executed under one roof to guarantee lot-to-lot consistency.
  • Clean Room Standard: State-of-the-art Class 10,000 (ISO Class 7) cleanrooms prevent bioburden and particulate contamination during product assembly.
  • Comprehensive Testing Laboratory: Every batch undergoes rigorous physical, chemical, flow-rate, tensile, leak, and sterility (bioburden & endotoxin) testing prior to release.
  • CDMO & OEM Flexibility: Custom tubing lengths, private-label branding, multi-lingual pouch printing (Portuguese/English), custom kit configurations, and specialized barcode placement for EU distribution.

Frequently Asked Questions for Portuguese Procurement Officers

Essential answers regarding regulatory documentation, product customization, minimum order requirements, and shipping logistics for importing medical disposables into Portugal.

1. What regulatory documentation does Angiplast provide for INFARMED product registration in Portugal?
We issue complete regulatory compliance files required for INFARMED database registration. This includes ISO 13485:2016 certification, CE Mark Technical Files (EU MDR compliant), Notarized/Apostilled Free Sale Certificates (FSC), Material Safety Data Sheets (MSDS), Biocompatibility Reports (ISO 10993), and Sterilisation Validation Summaries (EN ISO 11135).
2. Are your transfusion sets 100% Latex-Free and available in DEHP-Free polymer options?
Yes. All Angiplast transfusion and infusion sets are completely latex-free to avoid allergic reactions. Furthermore, we offer DEHP-free PVC formulation and TPE (Thermoplastic Elastomer) alternatives specifically engineered to comply with Western European environmental and patient safety directives.
3. What are the typical ocean freight shipping lead times and entry ports for Portugal?
We ship direct container loads (FCL) or consolidated freight (LCL) to major Portuguese ports, including the Port of Lisbon (Porto de Lisboa) and Port of Leixões (Porto). Typical transit time from our facility via Mundra/Nhava Sheva ports to Portugal ranges between 22 to 28 days. Express air freight is also available for urgent hospital tender demands via Lisbon Airport (LIS).
4. Can Angiplast accommodate private-label packaging and Portuguese language IFUs?
Absolutely. Our in-house design and packaging department supports full OEM/private-label services. We manufacture customized primary sterile peel-pouches and outer shipping cartons printed with Portuguese branding, multi-lingual Instructions for Use (IFU in Portuguese and English), and GS1-compliant UDI barcodes.
5. How does the leukocyte filter in your blood sets protect transfusion recipients?
Our specialized leukocyte depletion filter utilizes a high-efficiency 20–40 micron polyester/polypropylene mesh matrix that traps micro-aggregates, donor white blood cells, and cellular debris while allowing intact red blood cells to pass unimpeded. This drastically reduces the incidence of febrile non-haemolytic transfusion reactions, HLA alloimmunization, and cytomegalovirus (CMV) transmission.
6. What is the Minimum Order Quantity (MOQ) for OEM order shipments to Portugal?
For standard catalog items, initial trial orders can start at lower quantities (e.g., 10,000 to 20,000 units per SKU). For custom OEM/private-label configurations with specialized Portuguese packaging, MOQs generally equal one full production lot (typically 30,000 units), optimized for maximum freight efficiency.

Partner with a Trusted Global Transfusion Set Manufacturer

Expanding your medical product portfolio in Portugal or bidding for SNS hospital tenders? Connect with our dedicated export engineering team to request product samples, technical dossiers, and competitive factory-direct pricing.

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