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ISO 13485 & CE MDR Certified Medical OEM

Top Trusted Blood Control Technology IV Catheter Manufacturers & Factories for the Spain Market

Precision-Engineered Safety Peripheral Intravenous Catheters with Automatic Needle Shielding & Zero-Blood-Exposure Valves for Spanish Hospitals (SNS) & Medical Distributors

Factory Direct Product Range

Blood Control Technology IV Catheters & Safety Access Devices

Explore our hospital-grade, CE-marked intravenous access consumables engineered to meet Spanish AEMPS regulatory frameworks and European Sharps Directive 2010/32/EU.

Safety Blood Control IV Catheter 14G to 26G
BCT Safety Series

Good Price 14G-26G Color Coded Blood Control IV Cannula

Integrated self-sealing internal septum valve stops blood backflow upon needle withdrawal, ensuring zero blood spill during luer-lock hub connections.

  • Gauges: 14G, 16G, 18G, 20G, 22G, 24G, 26G
  • Tubing: FEP / Polyurethane (PUR)
  • Sterilization: EO Gas, Non-Pyrogenic
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Disposable Sterile Stainless Steel IV Cannula
Hospital Outpatient

Disposable IV Cannula Stainless Steel Sterile Pack OEM

Tri-facet bevelled Japanese stainless steel needle design paired with lubricated catheter shaft for minimal tissue trauma during venipuncture.

  • Hub Type: Pen-type & Winged
  • Packaging: Medical Blister Pack
  • Standard: ISO 10555-5 Compliant
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Butterfly Winged Blood Control IV Catheter
Winged / Flexible

Butterfly IV Cannula for Intravenous Infusion & Access

Flexible color-coded wings offer secure skin anchoring, reducing mechanical phlebitis risks in prolonged indwelling peripheral therapy.

  • Wing Design: Foldable & Ergonomic
  • Blood Control: Passive Septum Hydrophobic Filter
  • Shelf Life: 5 Years Sterile Guarantee
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CE ISO 13485 18G Butterfly IV Catheter with Injection Port
Ported & Winged

CE ISO 13485 18G Butterfly IV Catheter with Injection Port

Equipped with a non-return snap-cap injection valve for rapid bolus medication administration without secondary needle puncture.

  • Size: 18G High Flow Rate (90 ml/min)
  • Feature: One-Way Silicone Valve Port
  • Certification: CE 0123 / ISO 13485
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Micro Gauge 22G 24G 26G Safety IV Catheter
Paediatric & Micro

Disposable 22G 24G 26G Paediatric & Clinical Safety Catheter

Ultra-thin wall catheter geometry maximizing volumetric flow rate for small, fragile venous pathways in pediatric and clinical oncology settings.

  • Gauges: 22G (Blue), 24G (Yellow), 26G (Violet)
  • Flashback: Transparent Chamber Confirmation
  • Safety Clip: Passive Tip Encapsulation
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Wholesale IV Cannula with Flashback Chamber
B2B Bulk Export

Wholesale Disposable IV Cannula Catheter with Flashback Chamber

Optical-clarity flashback chamber providing immediate visual feedback of successful vein penetration before stylet withdrawal.

  • Chamber: High-Transparency Hydrophobic Plug
  • Needle: Radio-Opaque Stripe Catheter
  • OEM: Custom Brand Packaging Available
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Safety Intravenous Catheter Medical Consumables
Closed Safety System

Veterinary & Human Safety Intravenous Catheter System

Designed for versatile clinical, emergency, and veterinary applications demanding robust blood containment and passive needle protection.

  • Material: DEHP-Free & Latex-Free Medical Grade
  • Valve Test: Multi-Puncture Pressure Tested
  • Hub: Standard Luer Lock Connector
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Veterinary IV Cannula Full Size Spectrum
Full Spec Range

Veterinary & Clinical IV Cannula Full Size Range 14G-26G

Comprehensive size portfolio optimized for animal hospitals, trauma clinics, and specialized surgical centers across Spain and Europe.

  • Full Spectrum: 14G to 26G ISO Standard
  • Needle: Medical Grade SUS 304 Stainless Steel
  • Compliance: Spanish AEMPS & EU MDR Ready
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Engineering Excellence in Blood Control Technology (BCT): Solving Blood Exposure in Peripheral Access

Peripheral intravenous catheterization (PIVC) remains the single most common invasive medical procedure performed in modern hospital environments, with hundreds of millions of insertions executed annually across the European Union. However, traditional IV cannulas present two major clinical hazards during venipuncture: uncontrolled blood leakage from the catheter hub upon needle withdrawal and accidental needlestick injuries (NSIs) to healthcare personnel.

Blood Control Technology (BCT) represents a fundamental biomechanical advancement in vascular access safety. Engineered with an internal self-sealing elastomeric septum valve located directly inside the catheter hub, BCT automatically restricts the flow of blood from the vein until an extension set or luer-lock connection is securely attached. This internal valve mechanism functions completely passively, eliminating the manual compression step (such as digital occlusion of the vein) historically performed by nurses—a maneuver notorious for inconsistent blood control and touch-contamination risks.

Clinical Information Gain: Comparative hospital trials indicate that implementing Blood Control Safety IV Catheters reduces blood exposure events by over 95%, slashes bed-linen and dressing contamination costs, and substantially lowers risk of blood-borne pathogen transmission (HBV, HCV, HIV) among emergency and intensive care nursing staff.

Integrated Internal Septum Valve

Multi-use internal silicone valve opens seamlessly upon luer insertion and automatically reseals upon disconnection, stopping blood egress during multiple line changes.

Passive Needle Shielding Clip

An internal stainless steel clip automatically encapsulates the sharp needle tip immediately as the stylet is withdrawn from the hub, requiring no additional activation steps.

Double Flashback Technology

Instant visual confirmation of successful needle insertion into the vein wall followed by rapid catheter flashback, maximizing first-stick insertion accuracy.

95%+
Blood Leakage Reduction
100%
Passive Needlestick Shielding
20+
Years Manufacturing Authority
100+
Global Export Markets

Localized Application Scenarios: BCT IV Catheters across Spain’s Regional Health Services

Spain’s decentralized national healthcare system—the Sistema Nacional de Salud (SNS)—is governed through 17 Autonomous Community health services including CatSalut (Catalonia), SAS (Servicio Andaluz de Salud), SERMAS (Madrid), and Sacyl (Castilla y León). Each autonomous health authority maintains stringent protocol standards for vascular access, placing high priority on patient safety, infection prevention, and nurse occupational protection.

1. Emergency Services & SAMUR / SUMMA 112 Rapid Triage

In high-velocity emergency departments (Urgencias Hospitalarias) and mobile ICU ambulances across Madrid and Andalusia, paramedics encounter uncooperative, trauma, or hypotensive patients. Blood Control Safety IV Catheters eliminate blood splatter inside fast-moving vehicles and crowded trauma bays, allowing clinicians to stabilize line connections without contaminating sterile fields or field equipment.

2. Oncology & Day Hospitals (Hospitales de Día)

Chemotherapy and biotherapy regimens require frequent IV line flushes, blood sampling, and secondary infusions. The self-sealing BCT septum valve permits multiple luer access events without exposing oncology patients with compromised immune systems to airborne pathogens or environmental contamination at the catheter hub.

3. Paediatric Wards & Neonatal ICUs (UCIN)

Infants and pediatric patients present delicate, hyper-responsive venous vasculature. Utilizing ultra-fine 24G and 26G Blood Control IV Cannulas engineered with soft, biocompatible Polyurethane (PUR) reduces vein wall trauma while stopping blood loss that could induce anemia or distress in micro-premature infants.

4. Private Hospital Groups & Surgical Centers

Leading private healthcare consortiums in Spain—such as Quirónsalud, Vithas, and HM Hospitales—increasingly specify Blood Control Technology IV Catheters to minimize post-operative catheter-related bloodstream infections (CRBSIs), streamline nursing workflow, and uphold top-tier Joint Commission International (JCI) accreditation benchmarks.

Spain Market Trends & Regulatory Compliance Matrix: EU MDR 2017/745 & AEMPS Requirements

Procuring single-use medical consumables for the Spanish market mandates compliance with rigorous regulatory frameworks supervised by the AEMPS (Agencia Española de Medicamentos y Productos Sanitarios) under the umbrella of the European Union Medical Device Regulation (EU MDR 2017/745).

Regulatory / Trend Vector Spanish & EU Mandate Requirement Lars Medicare Compliance Standard
European Sharps Directive Directive 2010/32/EU mandatory adoption requiring Safety Engineered Devices (SEDs) in all hospital wards. 100% Passive Safety Shield Mechanism fully encapsulating needle tip on withdrawal; no active manual button needed.
EU MDR 2017/745 Certification Transition from MDD to MDR Class IIa non-invasive / invasive channel device technical documentation. CE certified by European Notified Body with complete Technical Documentation File, GSPR compliance, and UDI barcode tracking.
AEMPS National Registration Product listing on the Spanish Registro de Productos Sanitarios (CCPS) prior to commercial hospital distribution. Complete regulatory dossiers, Declaration of Conformity, IFU in Spanish language, and Free Sale Certificates (FSC).
Green Procurement & Eco-Design Public tenders in SNS demand phthalate-free, DEHP-free, and non-PVC materials with low-weight recyclable blister packaging. 100% DEHP-free and latex-free medical grade compounds tested per ISO 10993 biocompatibility guidelines.
Closed System Adoption Growing preference for integrated closed-loop IV catheter systems with pre-attached extension tubing to reduce touch contamination. Manufacturing capacity for both traditional ported IV cannulas and advanced integrated closed-system catheter assemblies.

Technical Specification Matrix: Blood Control Technology IV Catheter Series

Our IV cannulas and blood control safety catheters are color-coded in exact adherence to ISO 10555-5 global standards. Below is the complete engineering specification guide for hospital buyers and tenders:

Gauge Size Color Code Catheter O.D. (mm) Catheter Length (mm) Water Flow Rate (ml/min) Primary Clinical Application in Spain
14G Orange 2.1 mm 45 mm / 50 mm 270 - 290 ml/min Trauma, Rapid Blood Transfusion, Emergency Resuscitation
16G Grey 1.7 mm 45 mm 180 - 200 ml/min Major Surgical Procedures, High-Volume Parenteral Fluids
18G Green 1.3 mm 32 mm / 45 mm 85 - 105 ml/min Routine Surgery, Blood Transfusions, Intensive Care (UCI)
20G Pink 1.1 mm 32 mm 55 - 65 ml/min Standard Adult Inpatient Wards, IV Medication & Hydration
22G Blue 0.9 mm 25 mm 31 - 36 ml/min Geriatric Patients, Small Veins, Oncology Infusion Clinics
24G Yellow 0.7 mm 19 mm 18 - 22 ml/min Paediatric Care, Fragile Superficial Vein Cannulation
26G Violet 0.6 mm 19 mm 10 - 13 ml/min Neonatal Intensive Care (UCIN), Extremely Fine Micro-Veins
Direct Factory OEM & Manufacturing

20+ Years of Manufacturing Integrity & Cleanroom Precision

At Lars Medicare, we maintain complete operational ownership over every phase of medical disposable production. From custom mold tooling and automated injection molding to automated needle assembly, cleanroom packaging, and Ethylene Oxide (EO) sterilization, our unified manufacturing facility in Sonepat (Haryana) operates under a single ISO 13485:2016 quality management matrix.

Unlike trading intermediaries, our in-house tool room and automated optic quality-control systems allow us to modify catheter gauge specs, packaging dimensions, and private-label artwork rapidly without third-party bottlenecks. We provide fully compliant Spanish market OEM solutions for international medical distributors, private hospital groups, and public tender contractors.

Lars Medicare ISO Cleanroom Production Line for Safety IV Catheters
Purchasing & Regulatory Guide

Frequently Asked Questions by Spanish Importers & Hospital B2B Buyers

Clear, direct answers regarding regulatory compliance, OEM customization, minimum order quantities, and logistics for Spain and the EU.

1. Does Lars Medicare provide full AEMPS and EU MDR 2017/745 regulatory dossiers for Spain?

Yes. Every shipment of our Blood Control Technology IV Catheters and Safety IV Cannulas is accompanied by CE Certification issued under EU MDR standards, ISO 13485:2016 Quality System documentation, EC Declaration of Conformity, Certificate of Free Sale (CFS), and batch-specific Certificates of Analysis (CoA). We fully assist Spanish medical device importers with technical files required for AEMPS registration in the CCPS database.

2. Can we order customized private-label (OEM) packaging in Castilian Spanish?

Absolutely. We offer complete OEM and private-label manufacturing options. This includes customized blister film printing, multilingual Instructions for Use (IFU) in Castilian Spanish, UDI-ready GS1 compliant barcoding, custom inner carton packaging, and customized outer shipping boxes configured to match your brand specifications or Spanish regional tender requirements.

3. How does your Blood Control Technology prevent needlestick injuries compared to standard IV catheters?

Our device combines two essential safety barriers: First, an automatic passive needle-shielding clip encapsulates the sharp needle tip as it is pulled from the catheter hub, rendering the sharp safe without requiring manual clinician activation. Second, an internal elastomeric septum valve acts as a blood control barrier, preventing blood escaping from the catheter hub. This dual protection eliminates blood exposure and sharps injuries during high-stress procedures.

4. What are your typical Minimum Order Quantities (MOQs) and lead times for shipments to Spain?

For standard neutral-brand product SKUs, minimum order quantities start at 1 mixed pallet. For customized private-label OEM programs, MOQ is typically 50,000 units per gauge size depending on printing configurations. Standard lead times for repeat orders are 3 to 4 weeks, while initial OEM orders ship within 5 to 6 weeks following artwork approval and sterilization cycle validation.

5. Which Incoterms and Spanish ports of entry do you handle?

We work flexibly across FOB, CIF, and DDP (Delivered Duty Paid) Incoterms. Sea freight consignments are shipped via container ports at Nhava Sheva or Mundra directly to major Spanish maritime ports including **Valencia, Barcelona, Algeciras, and Bilbao**. Air cargo shipments are routed via Delhi (DEL) to **Adolfo Suárez Madrid-Barajas (MAD)** or **Josep Tarradellas Barcelona-El Prat (BCN)**.

6. Are your catheters available in both PUR (Polyurethane) and FEP materials?

Yes. We offer both Fluorinated Ethylene Propylene (FEP) and medical-grade Polyurethane (PUR) catheter formulations. Polyurethane catheters soften in situ at body temperature, minimizing mechanical vascular irritation, phlebitis, and catheter kinks, making them highly preferred in European hospital tenders.

7. How do you guarantee Ethylene Oxide (EO) sterilization validation and non-pyrogenicity?

Sterilization is conducted in-house using validated industrial Ethylene Oxide (EO) chambers adhering to ISO 11135 standards. Every production lot undergoes rigorous biological indicator testing, EO residue analysis, and bacterial endotoxin (LAL) testing to confirm non-pyrogenicity prior to formal QA release.

Partner with a Leading Blood Control Technology Manufacturer for Spain

Secure factory-direct pricing, guaranteed CE MDR documentation compliance, and premium safety IV catheter solutions tailored for Spanish healthcare procurement.

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