ISO 13485 & CE MDR CERTIFIED OEM/ODM MANUFACTURER

Top China Scalp Needle Supplier & Exporters

Precision-engineered scalp vein sets, winged infusion needles, long-term tunneled hemodialysis catheters, and clinical vascular access solutions serving global healthcare distributors in 70+ countries.

Sterile Single-Use Portfolio

High-Precision Scalp Needles & Dialysis Access Disposables

Manufactured in ISO Class 7 & 8 cleanroom facilities with Japanese SUS304 stainless steel, ultra-thin needle walls, and DEHP-free biocompatible polymers for atraumatic venipuncture.

Super Quality Permanent HD Catheter Set Silicone Cuffed Tunneled Dialysis Catheter 15F Long Term Hemodialysis Catheter Kit
Permanent HD Catheter Set Silicone Cuffed 15F Long Term
Radiopaque biocompatible silicone tunneled hemodialysis catheter kit with Dacron cuff for superior long-term vascular access integrity and infection control.
Size: 15Fr Material: Medical Silicone Sterilization: EO
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Surgical Pack Included EO Sterile Class III Hemodialysis Catheter for Clinical Dialysis Treatment Professional Medical Equipment
EO Sterile Class III Hemodialysis Catheter Surgical Kit
Complete clinical dialysis catheterization kit including introducer needle, guidewire, dilators, and scalpels designed for smooth vascular entry.
Class III Medical Double Lumen CE Marked
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Permanent Tunneled Hemodialysis Catheter Long Term Straight Dialysis Catheter Double Lumen Sterile HD Catheter
Permanent Tunneled Straight Double Lumen HD Catheter
Engineered polyurethane/silicone formulation offering optimum mechanical strength, kink-resistance, and high flow rate performance under continuous dialysis.
Double Lumen Tunneled Straight ISO 13485
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CE MDR Certified Transparent Silicone Single/Double/Triple Lumen Hemodialysis Catheter Medical Grade TPU Permanent Class II
CE MDR Medical Grade TPU Hemodialysis Catheter
Thermosensitive polyurethane catheter softens at body temperature, minimizing vessel wall damage while maintaining structural lumen integrity.
Single/Double/Triple TPU Material MDR Certified
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Professional Supplier Disposable Double Lumen Hemodialysis Catheter Kit Dialysis Catheter Kits
Disposable Double Lumen Short-Term Dialysis Kit
Short-term central venous catheter kit with soft tip technology, reducing endothelial trauma during acute kidney injury treatments.
Acute Hemodialysis 7Fr / 11.5Fr / 12Fr Soft Tip
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Medical Consumables Sterile Disposable Extracorporeal Circulation Hemodialysis Catheter Kit
Extracorporeal Circulation Hemodialysis Access Kit
High-flow blood tubing access lines and specialized vascular cannulae designed for seamless connection to hemodialysis blood pumps.
High Flow Extracorporeal DEHP Free
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Medical Supplies Hemodialysis Catheter Kit Double Lumen Dialysis Catheter 7Fr
Pediatric & Adult Double Lumen Catheter Kit 7Fr
Precision-crafted 7Fr double lumen catheter set with color-coded extension lines, extension clamps, and injection caps for clinical safety.
7Fr Gauge Color-Coded Biocompatible
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Medical Wholesale Dialysis Catheters for Hemodialysis Plastic CE Medical Grade Monofil Gold Central Venous Catheter EOS 2 Years
Central Venous Catheter Kit Medical Grade EOS 2 Years
Class IIa central venous catheter kit validated for 2-year sterile shelf life, featuring micro-polished needle surfaces and flexible wing positioning.
CVC System 2-Year Shelf Life Wholesale Bulk
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36+
Years Manufacturing Excellence
70+
Global Export Markets
100k+
Class 7/8 Cleanroom (Sq. Ft.)
400+
ISO & CE Certified SKUs

Engineering Excellence in Scalp Vein Sets & Vascular Access Manufacturing

In modern clinical infusion therapy and hemodialysis management, the single-use scalp needle—commonly referred to as a scalp vein set or butterfly needle—is an indispensable vascular access device. Designed for rapid venipuncture, pediatric fluid administration, geriatric blood sampling, and continuous low-flow intravenous therapies, the structural integrity of the needle tip, wing flexibility, and lumen smooth bore directly govern clinical safety and patient comfort.

As a leading China scalp needle manufacturer and international exporter, our production methodology integrates advanced Japanese needle cannulation engineering with automated siliconization processes. By utilizing SUS304 medical-grade stainless steel with ultra-thin wall (UTW) geometry, our scalp vein sets achieve maximum inner flow diameter without compromising mechanical puncture stiffness.

Clinical Insight: The penetration force of a scalp vein needle is heavily dictated by bevel grind geometry and surface tribology. Our automated triple-bevel grinding system reduces initial skin insertion drag by up to 35% compared to standard double-bevel alternatives, significantly mitigating tissue trauma and hematoma risks.

Technical Anatomy of a High-Performance Scalp Vein Set

Every single-use scalp vein assembly consists of four critical engineered components, strictly adhering to ISO 6009 and ISO 10993 standards:

  • Triple-Bevel Siliconized Stainless Steel Cannula: Formulated with medical-grade dimethicone coating to minimize friction coefficient during vascular entry.
  • Color-Coded Flexible Butterfly Wings: Molded from medical PVC or non-phthalate elastomers, featuring tactile ridges for secure non-slip clamping during insertion and anatomical flat seating during fixation.
  • Kink-Resistant Medical PVC/TPU Tubing: High-clarity, DEHP-free transparent tubing ranging from 15cm to 30cm, allowing immediate visual detection of blood flash-back while maintaining elasticity under bending pressures.
  • Precision Luer Lock / Slip Connector: Female Luer fitting compliant with ISO 80369-7, outfitted with a protective cap to ensure hermetic sealing prior to line connection.

Standardized Scalp Needle Gauge Specification Matrix

To support global hospital procurement and tender requirements, our scalable production lines manufacture scalp needles across full ISO 6009 color-coded spectrums:

Needle Gauge (G) ISO Color Code Outer Diameter (mm) Inner Diameter (mm) Tubing Length (mm) Primary Clinical Application
18G Pink 1.20 mm 0.84 mm 300 mm Rapid blood transfusion, high-viscosity fluid infusion
19G Cream / Ivory 1.10 mm 0.76 mm 300 mm Surgical fluid bolus, large vein access
20G Yellow 0.90 mm 0.60 mm 300 mm Routine adult IV therapy & diagnostic blood draw
21G Deep Green 0.80 mm 0.51 mm 300 mm General hospital ward administration, pediatric bolus
22G Black 0.70 mm 0.44 mm 300 mm Fragile vein infusion, oncology & geriatric care
23G Deep Blue 0.60 mm 0.37 mm 300 mm Pediatric venipuncture, scalp vein access in neonates
25G Orange 0.50 mm 0.28 mm 300 mm Neonatal intensive care unit (NICU), delicate vessels
27G Grey 0.40 mm 0.21 mm 300 mm Micro-infusion, specialized pediatric diagnostic sampling

Manufacturing Integrity: Cleanroom Automation & Quality Assurance

Quality reliability is non-negotiable when exporting sterile medical disposables. Our manufacturing complex in China spans over 100,000 square feet of certified ISO Class 7 and Class 8 cleanrooms operating under rigid ISO 13485 quality management systems. Every batch of scalp needles and dialysis catheter kits undergoes stringent automated optical inspection (AOI) for bevel burr detection, lumen blockage, and silicone uniformity.

Sterilization processes utilize strictly monitored Ethylene Oxide (EO) gas chambers compliant with ISO 11135 guidelines. Residual EO limits are systematically verified through gas chromatography to levels far below 10 ppm, guaranteeing non-pyrogenic, non-toxic, and biocompatible performance upon arrival at international healthcare facilities.

Why Global Importers Partner With Us

China's Leading Export Hub for Scalp Vein Sets & Dialysis Consumables

Combining competitive scale economics with uncompromising European MDR regulatory compliance to deliver turnkey OEM, private label, and bulk contract manufacturing.

ISO 13485 & CE MDR Compliant

Complete technical documentation dossiers (STED), Free Sale Certificates (FSC), ISO 10993 biocompatibility test reports, and CE MDR certificates ready for immediate regional MOH registration.

Global Export Supply Chain

Exporting to over 70 nations across Europe, Middle East, Latin America, Africa, and Southeast Asia. Optimized logistics with sea/air port dispatch from Shanghai, Ningbo, and Shenzhen ports.

Flexible OEM / Private Label Services

Custom packaging, sterile pouch artwork proofing, multilingual IFUs, localized UDI barcode generation, and custom tubing length/gauge combinations tailored to distributor contracts.

End-to-End Quality Control

Automated visual inspection system for needle sharpness, 100% pressure leak testing for luer joints and wings, bioburden testing, and particulate matter verification per ISO 8536-4.

Competitive Factory-Direct Value

High-volume automated production lines minimize unit cost while ensuring zero batch-to-batch variation, delivering max profit margin protection for hospital tender suppliers.

Integrated Clinical Solutions

One-stop supply capability spanning scalp vein sets, safety IV cannulae, blood transfusion sets, hemodialysis catheter kits, and urinary drainage disposables.

Future Procurement Trends in Scalp Needle & Vascular Access Markets (2025–2030)

The global demand for scalp vein sets and specialized vascular access devices is experiencing significant transformation driven by strict needle-stick safety mandates, shifting environmental regulations, and hospital tender cost pressures. Key trends reshaping procurement decisions include:

1. Global Adoption of Safety Retractable Scalp Vein Needles

Healthcare worker safety protocols, enforced by OSHA in North America and EU Directive 2010/32/EU in Europe, are accelerating the replacement of traditional scalp vein sets with active and passive safety retractable butterfly needles. Modern safety mechanisms feature an integrated protective shield that slides over the cannula immediately upon withdrawal from the vein, locking audibly to eliminate accidental needle-stick injuries and reuse risks.

2. Transition to Non-DEHP, Phthalate-Free & TPU Elastomers

Regulatory bodies such as the US FDA and EU ECHA are tightening restrictions on conventional PVC plasticizers containing DEHP (Di(2-ethylhexyl)phthalate). Future-ready medical disposables manufacturers are transitioning to polyurethane (TPU) and TOTM-plasticized PVC tubing. These advanced medical-grade materials prevent chemical leaching during prolonged intravenous therapy, rendering them safer for neonates, pregnant women, and oncology patients undergoing chemotherapy.

3. Integration of Needleless Connectors & Closed System Transfer Devices (CSTDs)

To reduce catheter-related bloodstream infections (CRBSIs) and contamination during intravenous administration, scalp vein sets and central lines are increasingly specified with pre-attached needleless luer valves and positive displacement connectors. This closed-system architecture safeguards both clinician and patient from fluid exposure and bio-hazardous pathogens.

4. Supply Chain Diversification & Direct-to-Manufacturer OEM Partnership

In response to international supply chain disruptions, global medical purchasing organizations and regional tenders are bypassing third-party traders in favor of direct engagement with verified China scalp needle manufacturers. Direct factory partnerships ensure strict quality audit oversight, customized buffer inventory arrangements, and transparent production lead times.

Frequently Asked Questions

Procurement & Technical FAQ for Hospital Suppliers & Distributors

Get instant clarity on quality certifications, OEM customization, sample dispatch, and international export procedures.

Which quality certifications do your scalp needles and medical disposables carry? +
Our cleanroom manufacturing facility operates under a Quality Management System certified to ISO 13485:2016 and ISO 9001. Our primary product lines—including scalp vein sets, hemodialysis catheter kits, and IV infusion sets—carry full CE Certification under EU MDR 2017/745 regulations. Technical files, Certificates of Analysis (CoA), biological indicators, and sterility release dossiers are supplied with every shipment batch.
What is the Minimum Order Quantity (MOQ) and standard delivery lead time for export orders? +
For standard catalogue items under our factory brand, the minimum order quantity starts at 10,000 pcs per gauge size (or 1 pallet equivalent). For OEM private-label packaging programs, MOQ typically begins at 50,000 pcs per SKU. Standard shipping lead time is 3 to 4 weeks following artwork approval and deposit confirmation. Urgent container shipments can be expedited upon request.
Can you provide custom needle gauges, tubing lengths, and private-label packaging artwork? +
Yes, full OEM/ODM customization is our core enterprise advantage. We support custom needle cannula length (1/2" to 1"), custom tubing length (from 15cm up to 30cm), specialized wing color branding, primary blister pack printing, inner box packaging layout, and barcode/UDI system integration. Digital proofing artwork is prepared within 5 working days for client review prior to mass production.
How is sterilization executed and validated for exported single-use needles? +
All scalp vein sets and dialysis catheter kits are sterilized via Ethylene Oxide (EO) gas processing conforming to ISO 11135 standards. Each sterilization cycle is validated with chemical indicators, biological indicators (Bacillus atrophaeus), bioburden analysis, and EO gas residue testing. Products carry a certified 5-year sterile shelf life when kept in undamaged blister packaging.
Do you supply official documentation to assist in regional Ministry of Health product registration? +
Absolutely. Our dedicated regulatory affairs team provides complete registration support dossiers, including Free Sale Certificates (FSC), ISO 13485 certificates, CE Declaration of Conformity, ISO 10993 Biocompatibility test summaries (Cytotoxicity, Sensitization, Irritation, Hemolysis), Sterilization Validation Reports, and stability testing data. Legalization or Apostille by local embassies can be arranged upon request.
How can global buyers request evaluation samples and competitive factory quotes? +
You can request product evaluation sample kits directly by clicking our online live inquiry buttons or reaching out to our export desk. Free sample packs (including assorted scalp needle gauges and hemodialysis samples) are dispatched within 48 hours via DHL/FedEx. Quotations are provided on FOB, CIF, or CFR terms within 24 hours of receiving your detailed SKU quantity schedule.

Partner with China's Premier Scalp Needle & Medical Disposable Factory

Looking for reliable bulk supply, superior clinical quality, and hassle-free registration support? Contact our global export team today for technical datasheets and instant factory pricing.

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