High-specification medical disposables manufactured under stringent ISO 13485 oversight, tailored for German purchasing groups (GPOs), hospital networks, and medical distributors.
In modern clinical vascular access, the Scalp Vein Set—commonly referred to in European medical nomenclature as a winged infusion set or butterfly needle—represents a vital device for intravenous fluid administration, phlebotomy, and rapid medication delivery. Engineered to navigate fragile, small-caliber, or tortuous peripheral veins, the structural integrity and geometric precision of the cannula determine patient outcome, venipuncture success rate, and clinician safety.
As a premier Chinese manufacturer operating Class 7 and Class 8 controlled environment cleanrooms, our engineering paradigm addresses the stringent mechanical and biological requirements set forth by the European Medical Device Regulation (EU MDR 2017/745) and German DIN standards. Our scalp vein sets combine high-tensile Japanese stainless steel needles with bio-compatible, DEHP-free polymer tubing, ensuring zero elastomer leaching and minimal vein wall trauma.
Precision-milled triple-faceted lancet bevel with automated micro-siliconization reduces penetration force by over 35%, ensuring painless initial insertion.
Color-coded flexible PVC/TPU wings engineered according to ISO 6009 provide ergonomic tactile control during venipuncture and secure anatomical anchoring.
Medical-grade DEHP-free PVC or TPU extension lines (30 cm default length) maintain consistent fluid dynamics even under extreme bending angles during patient transport.
Information Gain Insight: Unlike standard rigid IV cannulas, our advanced Scalp Vein Sets integrate a low dead-space design coupled with a female Luer Lock fitting. This configuration mitigates fluid retention inside the line, ensuring precise dosage delivery of high-potency drugs in pediatric oncology and neonatal intensive care units (NICUs).
To facilitate seamless inventory harmonization for German medical purchasing groups (GPOs) and hospital logistics centers, our scalp vein sets strictly adhere to international color coding and outer diameter specifications:
| Gauge Size | Color Code (ISO 6009) | Needle Outer Diameter (mm) | Nominal Flow Rate (mL/min) | Primary Clinical Application in German Hospitals |
|---|---|---|---|---|
| 18G | Pink | 1.20 mm | > 90 mL/min | Rapid fluid resuscitation, blood transfusion, adult trauma care |
| 20G | Yellow | 0.90 mm | 60 – 70 mL/min | General adult IV therapy, surgical ward fluid replacement |
| 21G | Green | 0.80 mm | 45 – 50 mL/min | Routine diagnostic blood sampling, outpatient infusion clinics |
| 22G | Black | 0.70 mm | 30 – 35 mL/min | Geriatric venipuncture, oncology drug administration |
| 23G | Deep Blue | 0.60 mm | 15 – 22 mL/min | Pediatric venipuncture, fragile vein access in ambulatory care |
| 25G | Orange | 0.50 mm | 8 – 11 mL/min | Neonatal care (NICU), micro-dosing infusers, delicate pediatric access |
| 27G | Grey | 0.40 mm | 4 – 6 mL/min | Specialized pediatric ophthalmology, ultra-fine vascular access |
Germany's healthcare architecture—comprising over 1,900 acute care hospitals (Krankenhäuser), University Hospitals (Universitätsklinika), and specialized outpatient surgery centers (Ambulante OP-Zentren)—imposes rigorous clinical protocols regarding infection control, catheter-related bloodstream infection (CRBSI) reduction, and ergonomic safety.
In facilities such as Charité Berlin or Universitätsklinikum Heidelberg, neonates require non-traumatic venous access. Our 25G and 27G scalp vein sets feature ultra-flexible wings that conform smoothly to scalp or dorsal hand contours, minimizing displacement during Movement.
Germany’s aging demographic increases demand for short-term hydration and pain management in mobile nursing services (Ambulante Pflegedienste). The siliconized ultra-thin needle wall permits insertion into sclerotic or collapsed veins without causing painful extravasation.
Short-duration infusions of cytostatic agents or biologicals require absolute connection security. Our integrated Luer Lock mechanisms eliminate accidental disconnects, safeguarding clinical staff against exposure to hazardous drugs.
Navigating the German medical device marketplace demands strict conformity with regulatory frameworks established by the European Union and enforced locally by the Federal Institute for Drugs and Medical Devices (BfArM). Importers, purchasing groups (such as Sana Einkaufsgemeinschaft, Asklepios, or Helios), and wholesale distributors must ensure their supply partners maintain complete technical documentation dossiers.
Sustainability in German Medical Procurement (Green Procurement): German procurement tenders increasingly weigh the environmental footprint of medical consumables. Our manufacturing facility in China integrates rooftop photovoltaic solar arrays, high-efficiency closed-loop injection molding machines, and reduced-plastic blister packaging to support green hospital initiatives.
With over 36 years of industrial excellence since 1988, our manufacturing enterprise bridge the gap between high-volume cost efficiency and uncompromising German quality expectations. Operating out of state-of-the-art facilities equipped with ISO Class 7 cleanrooms, we specialize in high-precision OEM and Private Label manufacturing for global medical brands.
Full Ethylene Oxide (EO) sterilization cycles validated per ISO 11135 standards, guaranteeing an assurance level of SAL 10^-6 with residual EO gas levels strictly below EN ISO 10993-7 thresholds.
100% inline optical camera inspection systems detect needle bevel burrs, siliconization uniformity, and wing symmetry before pouch sealing, ensuring zero defective units ship.
Comprehensive artwork customization, multi-lingual IFUs (German, English, French, Spanish), custom carton sizing, and regulatory dossier support for rapid registration in Germany.
We provide seamless end-to-end container shipment options optimized for German entry hubs. Whether shipping via Sea Freight to Hamburg / Bremerhaven or Express Air Freight to Frankfurt Airport (FRA), our dedicated export desk handles export customs clearance, Bill of Lading generation, and Certificate of Analysis (CoA) documentation for friction-free delivery.
Essential technical, regulatory, and commercial inquiries answered by our regulatory affairs and export management team:
Our Scalp Vein Sets are backed by ISO 13485:2016 Quality Management System certification, EU MDR 2017/745 Technical Files, CE Certificates issued by accredited Notified Bodies, Free Sale Certificates (FSC), and ISO 10993 Biocompatibility Test Reports. Batch-specific Certificates of Analysis (CoA) and EO Sterilization Release Certificates are supplied with every consignment.
Yes. In addition to standard scalp vein sets, we supply safety butterfly needles equipped with an integrated needle protective shield. Once venipuncture is completed, the clinician activates the safety mechanism, permanently enclosing the contaminated needle tip to fulfill German TRBA 250 requirements and prevent accidental needle-stick injuries.
For standard catalogue items under our brand, MOQ starts at 50,000 units per gauge. For custom OEM private-label packaging (with customized German IFUs and barcode artwork), the minimum order quantity is typically 100,000 units. Standard production lead times range from 3 to 4 weeks post-artwork approval, with sea transit to Hamburg taking approximately 28 to 35 days.
All our scalp vein sets are 100% natural rubber latex-free to eliminate allergic reactions. We offer tubing formulations in DEHP-free PVC (using non-phthalate plasticizers such as DINCH/TOTM) as well as medical-grade Polyurethane (TPU) for absolute chemical inertness during sensitive infusions.
Yes, our regulatory department provides complete Single Registration Number (SRN) data, Basic UDI-DI codes, and technical documentation required by your Authorized Representative (EC REP) or German importer to register the products within EUDAMED and the German BfArM system.
We source high-tensile AISI 304 stainless steel tubing and employ automated CNC triple-bevel grinding machinery. Every needle tip undergoes automated 100% optical vision sorting to reject burrs or structural anomalies, followed by micro-dose siliconization to guarantee uniform insertion forces below 0.15N.
Elevate your medical product supply chain in Germany with CE MDR certified, precision-engineered scalp vein sets and dialysis consumables. Contact our export desk today for factory pricing, sample kits, and technical dossiers.
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