CE Certified Mucus Extractor Manufacturer & Supplier

Global B2B Solutions for Medical-Grade Neonatal & Adult Aspiration Devices. Engineered for Superior Biocompatibility, Precision Fluid Collection, and Flawless Clinical Safety.

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Foshan Wigivida Medical Co., Ltd.

A trusted name in globally compliant medical device manufacturing, advancing respiratory, urological, and surgical care.

Foshan Wigivida Medical Co., Ltd. is a leading China-based manufacturer of high-quality medical consumables and devices, specializing in respiratory products, medical tubes, urology products, hypodermic and surgical consumables. With years of dedicated experience in the healthcare industry, Wigivida has built a reputation for providing reliable, safe, and innovative solutions to hospitals, clinics, and medical distributors worldwide.

The company offers a comprehensive product range, including oxygen masks, ventilator accessories, catheters, Foley catheters, hypodermic needles, syringes, surgical drapes, sterile gloves, sutures, cotton swabs, gauze rolls, IV sets, and disposable medical kits. Each product is manufactured with strict adherence to quality standards, ensuring biocompatibility, durability, and patient safety.

Wigivida Production Facility Overview
100K
Clean Room Class (ISO 8)
CE / ISO
Regulatory Compliance
80+
Exporting Countries
100%
Medical Grade Raw Materials

Technical Monograph: Clinical Efficacy of Mucus Extractors

A mucus extractor is an essential medical device designed specifically for aspirating secretions from the upper respiratory tract of neonates, infants, or adult patients in critical care. It acts as an intermediary collection chamber between a suction catheter and a manual or mechanical vacuum source. The primary clinical imperative of this device is to secure airway patency quickly while preventing cross-infection between the patient, the collection apparatus, and medical personnel.

"In neonatal resuscitation, the rapid clear-pathway clearing of meconium, mucus, and amniotic fluid is critical. The design parameters of a mucus extractor directly determine clinical outcomes and safety profiles."

Clinical Engineering and Design Architecture

Wigivida’s CE certified mucus extractors are developed under strict clinical guidelines to provide maximum control, visualization, and hygiene:

  • Hydrophobic Microbiological Barrier: Integrates a high-efficiency hydrophobic filter block in the suction path. This barrier prevents retrograde aerosol contamination to the wall-mounted suction pipeline or manual aspirator bulb.
  • High-Clarity Graduated Chamber: Extruded from medical-grade, shatterproof Polypropylene (PP) or Polycarbonate (PC). The container features clear, wear-resistant graduations (commonly 20ml to 25ml) to enable precise volumetric and qualitative assessment of aspirated fluids.
  • Biocompatible Catheter Shaft: Formulated using medical-grade DEHP-free PVC or premium liquid silicone rubber. Designed with a satin surface finish to ease insertion while reducing mucosal trauma. The catheter tip is rounded and possesses two lateral eyes (distal ports) for atraumatic, balanced aspiration.
  • Dual-Function Cap Design: Includes a secondary solid sealing cap. Once the aspiration is complete, the catheter tubes can be discarded, and the chamber sealed immediately, transforming the unit into a secure transportation vial for microbiological specimen analysis.

Biocompatibility

ISO 10993 compliant. Phthalate-free and DEHP-free material formulations ensure zero chemical leaching during prolonged contact with vulnerable mucosal membranes.

Sterility Assurance

Sterilized via validated Ethylene Oxide (EO) gas procedures according to EN ISO 11135 standards. Guaranteed sterile barrier life cycle of 5 years in clean room packaging.

Dual-Safe Cap

The extra screw cap seals the graduated specimen tube instantly. This zero-leakage design eliminates biological hazards during internal transport to hospital laboratories.

Localization Support & Regulatory Compliance

Procuring medical devices globally requires more than finding a competitive price. Navigating regional regulatory environments is vital for supply chain resilience. At Wigivida, we prioritize localization support and rigorous compliance documentation to assure seamless customs clearance and clinical authorization.

CE Marking & EU MDR Compliance

All our mucus extractors conform strictly to the European Union Medical Device Regulation (EU MDR 2017/745). This standard mandates comprehensive clinical evaluation, post-market surveillance (PMS), and continuous safety testing. B2B buyers receive authorized declarations of conformity, technical documentation dossiers, and clean room validation records to facilitate rapid registration with national ministries of health.

Furthermore, our manufacturing systems are certified under ISO 13485:2016 (Medical Devices - Quality Management Systems), ensuring every production batch undergoes rigorous trace audits, raw material tracking, and visual inspection protocols.

Customized Localization Support

Medical consumables require regional adaptations to fit localized workflows. Wigivida supports international partners with:

  • Multilingual Labeling & IFU: Translation of Instruction for Use (IFU) documents and retail boxes into over 15 languages, including Spanish, French, German, Arabic, and Portuguese.
  • Diverse Connectors & Sizes: Availability of multiple adapter styles (funnel connector, capillary connector, finger control bypass) to interface cleanly with localized clinical vacuum setups.
  • Flexible Packaging Configurations: Choice of medical paper-plastic peel pouches or sterile blister packs configured for regional hospital group purchasing requirements.
Wigivida Advanced Assembly and Testing Line

Wigivida Medical emphasizes innovation, research, and precision manufacturing, combining advanced production technology with a rigorous quality management system. The company also provides customized solutions to meet the specific needs of healthcare providers, supporting efficient hospital workflows and minimizing infection risks.

Guided by the principles of "quality first, service first, and customer satisfaction-driven," Foshan Wigivida Medical Co., Ltd. has earned an excellent reputation both domestically and internationally. With a professional R&D team, modern manufacturing facilities, and dedicated after-sales service, the company continues to advance the medical consumables industry, delivering safe, effective, and high-quality healthcare solutions that improve patient outcomes and support global healthcare innovation.

China Manufacturing and Supply Chain Advantages

As a leading Chinese manufacturer located in the medical device production cluster of Foshan, Guangdong province, Wigivida harnesses geographic and technological scale to deliver high-quality devices cost-effectively.

Integrated Supply Base

Foshan’s medical supply cluster provides direct access to high-purity medical polymers, precision mold tooling, and automated packaging lines. This geographic concentration minimizes raw material lead times and insulates against global logistics shocks.

Automated Cleanrooms

We utilize automated injection molding and tube extrusion processes inside ISO Class 8 (100,000-class) cleanrooms. Automating critical assembly steps reduces human contamination risks, ensuring high batch-to-batch consistency and a low bioburden score.

Economies of Scale

Wigivida optimizes unit economics via high-volume output runs, passing cost savings to B2B distributors and healthcare systems. Our streamlined processes balance low manufacturing costs with strict regulatory adherence.

Localized Application Scenarios & Clinical Operations

Mucus extractors serve distinct clinical needs across healthcare departments. Understanding these applications helps procurement directors choose the correct configurations:

1. Neonatal Delivery Suites and NICU

During birth, infants may aspirate amniotic fluid, maternal blood, or meconium. Immediate suctioning using a soft-tip mucus extractor is vital to establish breathing. In neonatal intensive care units (NICU), the device is used for routine respiratory hygiene in ventilated infants. Our Fr6 to Fr10 catheter lines, featuring soft, flexible tips, prevent trauma to sensitive nasal and oral mucosa.

2. Emergency Medical Services (EMS)

First responders rely on mucus extractors when mechanical suction is unavailable. The extractor can connect directly to manual hand pumps or operate via oral aspiration (where the clinician uses gentle mouth suction, protected by the device's internal filter). Compact packaging and long sterile shelf life make it a standard inclusion in emergency pediatric kits.

3. Pediatric Wards & Respiratory Therapy

For children presenting with acute bronchiolitis, pneumonia, or cystic fibrosis, clear airways are necessary to improve oxygenation. The mucus extractor helps clean thick bronchial secretions and collect clean samples for laboratory diagnosis, helping target treatment without requiring invasive suction systems.

4. Veterinary Medicine and Animal Care

Clearing airways immediately post-delivery is also critical in veterinary medicine. Standard human infant mucus extractors are widely adopted by veterinary clinics for clearing airways in newborn puppies, kittens, and small livestock, demonstrating the device's utility across clinical fields.

Global Procurement Strategies & Industry Trends

Hospital networks, ministries of health, and international distributors face distinct operational challenges when managing respiratory consumables. Modern medical procurement trends prioritize supply chain transparency, quality verification, and sustainability.

Key Procurement Benchmarks

For successful product integration and supply stability, B2B procurement professionals focus on three essential parameters:

  • Unit Packaging Integrity: Pouches must withstand high-altitude pressure changes during air freight without breaking, preserving the sterile barrier. Wigivida uses puncture-resistant Tyvek-grade paper-plastic configurations.
  • Traceability Dossiers: Global distribution requires easy access to clean room audits, bioburden statistics, sterilization records, and biocompatibility documentation.
  • Standardized Connector Types: International settings require compatibility. Our extractors feature color-coded funnel connectors matching ISO standards, ensuring straightforward hookups to bedside suction lines.

Next-Gen Industry Development

The medical disposables sector is shifting toward eco-conscious material science. Research focuses on introducing bio-based plastics and DEHP-free plasticizers that preserve flexibility while reducing environmental footprint. Wigivida invests in these materials to help health systems meet carbon reduction targets without compromising patient safety.

Clinical Q&A: Mucus Extractor Selection & Operation

Expert insights on regulatory compliance, product selection, and clinical parameters for B2B buyers and clinical specialists.

What regulatory documents are provided for European market clearance? +
Our mucus extractors are CE certified under the EU MDR 2017/745. We provide full regulatory dossiers, including ISO 13485:2016 certificate, EC Declaration of Conformity, Bioburden validation reports, EO gas sterilization residual test records (under EN ISO 10993-7), and Biocompatibility Evaluation Reports.
How does the hydrophobic filter function during high-vacuum clinical operations? +
The extractor features an integrated hydrophobic membrane in the upper chamber connector. This filter acts as a barrier that allows air flow but blocks fluids, thick mucus, and infectious aerosols. Even under high mechanical vacuum, it prevents fluids from bypassing the chamber and contaminating the suction system.
Can the mucus extractor be customized with private labeling (OEM/ODM)? +
Yes. Wigivida offers customizable OEM and ODM services. Partners can specify catheter lengths, tube diameters (French sizes Fr6 to Fr18), chamber sizing, connector colors, packaging styles, and localized multilingual labeling.
Is the device completely free of DEHP, Phthalates, and Latex? +
Yes, our mucus extractors are manufactured using medical-grade, DEHP-free PVC or pure silicone, and are 100% latex-free. This minimizes hypersensitivity risks in newborns and prevents chemical contamination of the collected specimens.
How is specimen transport handled after aspiration is complete? +
After aspiration, the tubes are disconnected and disposed of according to biohazard protocols. The provided screw-cap is tightened onto the container, sealing the specimen. The stable container base prevents tipping, and clear graduations simplify laboratory measurement.

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