Direct-from-factory access to MDR-compliant consumables across tissue acquisition, hemostasis, and endourological navigation.
Addressing the procedural rigors of modern endotherapy: from acute non-variceal upper gastrointestinal hemorrhage to deep mucosal defect closure following high-volume EMR and ESD procedures.
Acute peptic ulcer bleeding, Dieulafoy's lesions, and Mallory-Weiss tears necessitate immediate mechanical coaptation. Our repositionable hemoclips provide precise coaptive pressure exceeding arterial burst thresholds, halting brisk hemorrhaging without thermal tissue trauma.
Large mucosal resections in the colon and duodenum present severe delayed perforation and secondary bleeding hazards. Our wide-opening, high-retention endo clips facilitate complete mucosal approximation via zipper and tensioning techniques, eliminating surgical conversion risks.
Emergency transmural perforations during difficult endoscopic retrograde cholangiopancreatography (ERCP) or endoscopic submucosal dissection require immediate full-thickness or mucosal closure. Our high-tensile clip architectures anchor securely even in friable, inflamed parenchymal margins.
Eliminating quality variance and production bottlenecks. Integrating multi-axis CNC Swiss turning, robotic micro-assembly, and continuous optical inline verification.
Operating 7-axis CNC Swiss-type automatic turning centers capable of holding tolerances within ±0.003mm. Every claw joint, pin pivot, and locking wedge is crafted to guarantee repeatable mechanical deployment and release kinematics.
Eliminating human inspection fatigue via multi-angle high-resolution CCD cameras and neural-network surface detection. 100% of endoclip jaw tips and tension cables undergo inline dimensional verification before cleanroom packaging.
From raw wire drawing (Austenitic 304, 316LVM, Nitinol) to final EO sterilization, tooling manufacture and medical polymer extrusion sit inside our facility in Jiangxi, cutting third-party supply vulnerabilities and minimizing landed unit costs.
Comprehensive physical, mechanical, and material performance parameters across our standard and custom ODM hemoclip variations.
| Model Variant | Jaw Span (Open) | Working Length | Min. Channel Ø | Rotational Freedom | Repositionable | MR Status | Material Core |
|---|---|---|---|---|---|---|---|
| ZRH-HC-09S (Standard Hemostasis) | 9.0 mm | 1650 / 1950 mm | 2.8 mm | 360° Bidirectional | Yes (Multi-cycle) | MR Conditional (3T) | Austenitic 304 / Co-Cr |
| ZRH-HC-11M (Intermediate Closure) | 11.0 mm | 1950 / 2300 mm | 2.8 mm | 360° Synchronous | Yes (Multi-cycle) | MR Conditional (3T) | High Yield 17-7 PH Steel |
| ZRH-HC-13W (Wide Mucosal Closure) | 13.5 mm | 1950 / 2300 mm | 2.8 mm | 360° Synchronous | Yes (Multi-cycle) | MR Conditional (3T) | Nitinol Reinforced Base |
| ZRH-HC-16X (Deep Defect ESD/EMR) | 16.0 mm | 1950 / 2300 mm | 3.2 mm / 3.7 mm | 360° Direct Torque | Yes (Multi-cycle) | MR Conditional (3T) | Structural 316LVM Steel |
| Custom ODM Program | 7.0 – 18.0 mm | 1200 – 2700 mm | 2.0 – 3.8 mm | Custom Calibrated | Per Spec | Tested to ASTM F2503 | Tailored Metallurgical Alloy |
Navigating rigorous international regulatory hurdles with turn-key technical files, testing dossiers, and full Quality Management System transparency.
Complete Technical Documentation under EU MDR Class IIb / Class III rules. Full clinical evaluation reports (CER), post-market clinical follow-up (PMCF) plans, and risk assessments aligned strictly with ISO 14971:2019 standards.
Validated ethylene oxide (EO) sterilization programs satisfying ISO 11135, guaranteeing residual levels below limits defined by ISO 10993-7. Fully tested cytotoxicity, systemic toxicity, irritation, and hemocompatibility portfolios.
Accelerate your regional ministry of health registrations in Latin America (ANVISA, COFEPRIS), Southeast Asia, the Middle East, and beyond. We prepare customized Free Sales Certificates (CFS), stability reports, and localized technical dossiers.
Leading the clinical shift from simple mechanical clamps to intelligent, bio-integrative, and automated robotic-compatible closing solutions.
Transitioning to ultra-compact retained bases under 4.5mm in height, reducing unintentional endoscopic dislodgement when applying multiple adjacent clips during complex ESD closures.
Introducing magnesium-zinc alloy arm assemblies designed to maintain 100% mechanical holding tension for 14 days, followed by controlled resorption over 90 days, eliminating permanent foreign bodies.
Specialized multi-degree micro-wrist catheter integration engineered for compatibility with autonomous and surgeon-guided dual-channel robotic flexible endoscopic systems.
Miniature bio-impedance micro-sensors confirming immediate vascular coaptation combined with localized pro-coagulant peptide micro-coatings for refractory hemorrhagic lesions.
Tailored manufacturing partnerships for medical device multinational corporations, regional brand distributors, and healthcare group purchasing organizations.
Comprehensive custom branding options including sterile medical Tyvek® pouch heat-sealing, multi-lingual outer cartons, customized UDI (Unique Device Identification) barcode tagging, and custom IFU leaflets conforming to MDR labeling requirements.
Whether your clinical users require extended working lengths for enteroscopy (up to 2700mm), ultra-slim insertion sheaths for pediatric channels (2.0mm), or customized arm angles for enhanced mucosal grasp, our R&D team completes prototyping in 15 days.
Bridging production scalability with commercial agility. We offer competitive tiered pricing, low Initial Order Quantities (MOQ) for new market launches, dedicated buffer warehouse storage, and scheduled rolling supply deliveries.
Direct engineering and procurement answers regarding torque kinematics, retention force, MRI safety parameters, and custom contract manufacturing.
Expanding your medical supply chain with companion access tools, stone retrieval baskets, electrosurgical hot biopsy forceps, and specialized channel maintenance devices.
Connect directly with our biomedical engineering and international regulatory specialists. Obtain full product catalogs, CE/ISO certificates, testing dossiers, and tailored contract manufacturing quotations.