Urology / Negative Pressure
Explore our certified surgical consumables designed for minimally invasive stone retrieval, tissue sampling, therapeutic drainage, and gastrointestinal hemostasis.
Addressing the anatomical challenges of choledocholithiasis, tortuous biliary ducts, and mechanical entrapment through superelastic metallurgy and advanced catheter design.
Clinical Insight: In modern therapeutic Endoscopic Retrograde Cholangiopancreatography (ERCP), incomplete biliary duct stone clearance accounts for significant post-procedure complications, including recurrent cholangitis, acute pancreatitis, and secondary ductal stricturing. High-performance retrieval baskets serve as the frontline instrument to achieve definitive ductal hygiene, demanding zero-kink superelasticity, dynamic wire expandability, and foolproof emergency detachment capabilities.
Constructed from premium Nickel-Titanium (NiTi) shape-memory alloy calibrated to human body temperature ($A_f$ temperature < 32°C). Ensures consistent radial expansion force within the common bile duct, 100% elastic shape recovery after repeated deployment, and superior kink resistance during challenging distal biliary cannulation.
Multi-layer braided catheter core jacketed with low-friction fluoropolymer (PTFE). Translates micro-rotations directly from the ergonomic operating handle to the basket head, empowering endoscopists to capture elusive, migratory, or intrahepatic calculi without inducing papillary trauma or bile duct wall shearing.
Engineered with an ultra-high-tensile stainless steel pulling wire (> 150 N yield breaking strength). In the event of basket impaction on an oversized hard calculus (> 15mm), the basket seamlessly mates with emergency mechanical lithotriptors to crush the calculus in situ, eliminating emergency surgical conversion.
Standardized dimensional tolerance matched to major endoscope working channels (Olympus, Fujifilm, Pentax) and trans-papillary guidewires.
| Model Series | Basket Configuration | Basket Width (mm) | Outer Sheath (Fr / mm) | Working Length (mm) | Guidewire Port | Notified Regulatory Status |
|---|---|---|---|---|---|---|
| ZRH-EB4-D15 | 4-Wire Diamond (Dormia) | 15 mm ± 1.0 | 7.0 Fr (2.3 mm) | 1950 mm | 0.035" Guidewire Lumen | CE MDR Class IIa / FDA 510(k) |
| ZRH-EB4-D22 | 4-Wire Diamond (Dormia) | 22 mm ± 1.5 | 7.0 Fr (2.3 mm) | 1950 mm | 0.035" Guidewire Lumen | CE MDR Class IIa / FDA 510(k) |
| ZRH-EB6-H25 | 6-Wire Helical Spiral | 25 mm ± 1.5 | 7.0 Fr (2.3 mm) | 2000 mm | 0.035" Guidewire Lumen | CE MDR Class IIa / Free Sales Cert |
| ZRH-EB8-H30 | 8-Wire Multi-Strand Mesh | 30 mm ± 2.0 | 8.0 Fr (2.6 mm) | 1950 mm | Contrast Injection Compatible | CE MDR Class IIa / ISO 13485 |
| ZRH-EBM-Mini | 4-Wire Micro Helical | 12 mm ± 1.0 | 5.5 Fr (1.8 mm) | 2200 mm | Direct Cholangioscopy Spec | CE MDR / Custom OEM |
Anticipating the convergence of digital cholangioscopy, smart-sensing biomaterials, and energy-assisted lithotripsy architectures.
Ongoing engineering focuses on ternary Nitinol alloys (Ni-Ti-Cr / Ni-Ti-Co) providing micro-tunable radial pressure gradients. This prevents ductal spasm while maximizing gripping friction on smooth, cholesterol-rich gallstones without wire crossover or premature wire deformation.
Development of sub-3.0 Fr ultra-micro baskets configured specifically for single-operator digital cholangioscopy (SOC) working channels (e.g., Boston Scientific SpyGlass™ compatible). Facilitates targeted, direct visual lithotripsy and fragment clearance in intrahepatic ducts.
Next-generation platforms integrate dual-lumen channels that allow Holmium / Thulium laser fiber passage directly down the basket centerline, enabling simultaneous stone capture, laser fragmentation, and suction evacuation without device exchange.
Minimizing fluoroscopy times, avoiding cross-contamination risks, and reducing the total cost of choledocholithiasis management for healthcare networks.
100% single-use, sterile-barrier EO packaging eliminates the catastrophic patient infection vectors associated with reprocessing narrow, multi-wire mechanical lumen devices. Safeguards hospital epidemiology and fully satisfies CDC and ESGE guidelines.
High-visibility radiopaque markers positioned precisely at the basket distal tip and sheath junction provide exceptional fluoroscopic clarity. Endoscopists pinpoint basket deployment instantly, cutting procedure duration by up to 28% and lowering radiation exposure.
Eliminating intermediaries through direct OEM factory sourcing allows tertiary hospital networks and distributors to reduce per-procedure consumables procurement expenditure by 35–50% compared to legacy Western brands, without clinical compromise.
Complete technical dossiers, localized labeling, and rigorous biological safety validation adhering to European Regulation (EU) 2017/745 and FDA standards.
Class IIa medical device certification assessed under the stringent Medical Device Regulation (EU) 2017/745. Supported by comprehensive Clinical Evaluation Reports (CER) and Post-Market Surveillance (PMS) systems.
Full quality management system audited by international notified bodies. Complete traceability from Nitinol raw ingot batch numbers to sterile shelf packaging and final export container seals.
Full biological safety testing profiles, including cytotoxicity, intracutaneous reactivity, systemic toxicity, hemocompatibility, and pyrogenicity testing performed in GLP-accredited testing institutes.
Dedicated regulatory affairs team delivering country-specific Free Sales Certificates (FSC), Declaration of Conformity (DoC), multi-lingual Instructions for Use (IFU), and authorized EU/UK representative registrations.
Automated precision micro-assembly, vertical integration, and continuous digital quality monitoring inside our state-of-the-art production hub in Jiangxi.
From in-house precision catheter extrusion, PTFE wire coating, and Nitinol thermal shape-setting to ultrasonic washing and automated EO sterilization. Total internal control guarantees cost efficiency, uninterrupted raw material access, and zero reliance on outsourced subcontractors.
Equipped with high-precision fiber laser welding workstations. Automated multi-axis robotic fixtures form ultra-smooth, atraumatic bullet-style basket tips with zero burrs or sharp seams, ensuring zero bile duct lacerations even during aggressive intraductal sweeping.
Our Manufacturing Execution System (MES) enforces 100% digital checkpoints across every production stage. Individual sterile blisters carry 2D DataMatrix codes tracking tensile load test data, operator ID, cleanroom temperature, and EO residual degassing curves.
Flexible minimum order quantities, rapid prototyping, customized handle ergonomics, and bespoke contract manufacturing solutions for multinational healthcare brands.
Full private-label printing on sterile Tyvek® peel pouches, inner boxes, and master export cartons. Customization includes multilingual branding, regional barcodes (EAN-13, GS1 DataMatrix), and customized brand aesthetics suited for national healthcare tenders.
Tailor basket profiles to specific regional clinical preferences: Dormia diamond geometries for round gallbladder calculi, helical baskets for multiple biliary sludge/fragments, or specialized 8-wire baskets for high-friction grasping of smooth intraductal stones.
Bundle your ERCP basket consignments with sphincterotomes, PTFE hydrophilic guidewires, biliary drainage catheters, and biopsy forceps into unified ocean or air shipments, dramatically reducing customs clearance overhead and logistics fees.
Authoritative answers to common procurement, compliance, and procedural inquiries from medical distributors, regulatory officers, and clinical buyers.
Our ERCP extraction baskets incorporate a high-tensile internal pulling core rated to withstand > 150 N, paired with an emergency lithotripsy compatible handle design. Should a calculus prove too large to traverse the ampulla of Vater, the operator can remove the proximal handle and pass an emergency metal crushing sheath over the catheter to crush the stone mechanically without requiring surgical laparotomy.
4-wire diamond (Dormia) baskets generate higher radial expansion pressure and larger openings between wires, making them ideal for initial capture of single, well-defined calculi (8–15 mm). 6-wire and 8-wire helical baskets feature tighter inter-wire spacing, which excels at trapping multiple smaller biliary fragments, sludge, and preventing calculus escape during trans-papillary withdrawal.
The outer catheter is manufactured from high-density extruded PTFE (polytetrafluoroethylene) featuring an ultra-low dynamic friction coefficient (μ ≤ 0.04). Even when the duodenoscope Albarran elevator is articulated to maximum angle (> 90°), the internal pull wire slides smoothly without binding, allowing responsive opening and tactile stone tactile feedback.
Every shipment can be paired with our comprehensive Technical Documentation File (STED format), which includes our CE Certificate issued under EU MDR 2017/745, ISO 13485:2016 quality certificate, ISO 11135 Ethylene Oxide Sterilization Validation Report, ISO 10993 Biocompatibility Test Dossiers, Certificate of Analysis (CoA), and localized multi-lingual IFUs.
All baskets are individually sealed in medical-grade Tyvek® / PET-PE sterile blister pouches inside a Class 100,000 cleanroom, providing a validated 3-year sterile shelf life. Standard packaging consists of 10 pouches per inner box and 100 units per master shipping carton, lined with moisture-barrier foils and tested to ISTA-2A transport standards.
For standard factory-branded products, MOQ starts at 50 units with dispatch within 7 business days. For customized OEM private labeling (custom dimensions, laser-etched logos, branded blister artwork, and specific handle designs), MOQ is typically 500 units with an initial pilot validation lead time of 3–4 weeks.
Complement your ERCP baskets with matched biliary guidewires, rotatable hemoclips, and negative pressure access systems to streamline hospital tender orders.
