Precision-engineered diagnostic and therapeutic accessories ready for OEM contract branding, tender distribution, and tailored clinical custom-runs.
OEM Disposable Medical Nitinol Stone Extractor Retrieval Basket for Urinary
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CE Certified Reopen Rotatable Hemostasis Endoclip for Single Use
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OEM Disposable Endoscopic PTFE Nitinol Zebra Urology Guidewire
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Disposable Endoscopic Hemoclip (MDR CE Approved Mechanical Closure)
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GI Endoscopic Biopsy Forceps with Fenestrated Alligator Jaw Design
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CE Certified Gastrointestinal Hemostatic Clip for Endotherapy
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ODM EMR Endoscopic Injection Needle for Gastroscope & Bronchoscope
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Hydrophilic Flexible & Navigable Suction Ureteral Access Sheath
View Technical Data →The global flexible endoscopy market is undergoing an accelerated transformation. Driven by stringent cross-contamination guidelines (such as FDA alerts surrounding carbapenem-resistant Enterobacteriaceae [CRE] transmission via multi-use lumens), surgical providers and ambulatory surgical centers (ASCs) are aggressively migrating toward single-use accessories. This paradigm shift demands high-volume, defect-free manufacturing capabilities from specialized ODM partners.
Jiangxi ZhuoRuiHua Medical Instrument Co., Ltd. (ZHR Med) operates at the convergence of clinical-grade biomechanical engineering and scalable high-precision production. By consolidating design, micro-machining, polymeric extrusion, laser assembly, and cleanroom packaging under one unified ISO 13485:2016 infrastructure, we eliminate multi-tier supply chain markups while guaranteeing exact compliance with European MDR (EU) 2017/745 and US FDA frameworks.
Procurement directors face three structural pitfalls when contracting OEM/ODM medical consumables: premature mechanical fatigue in tortuous anatomy, batch-to-batch biocompatibility drift, and delayed regulatory technical documentation under MDR Annex IX.
ZHR Med executes dynamic tortuosity cycle testing (>180° retroflexion simulation) on every production lot of hemoclips, snares, and stone extractors prior to lot release.
Automated Ethylene Oxide (EO) sterilization compliant with ISO 11135, validated to an SAL of 10-6 with zero toxic residual ethylene chlorohydrin (ECH).
ZHR Med aligns tooling parameters and metallurgical properties with the exact clinical demands of the interventionist. Our ODM output spans six specialized endoscopy disciplines.
Ultra-sharp micro-welded stainless steel cups with laser-sharpened cutting profiles. Designed for clean tissue transection without micro-tearing artifacts, ensuring diagnostic yield in gastrointestinal and bronchoscopic mucosal tissue collection.
Re-positionable, fully rotatable mechanical hemoclips engineered for acute upper/lower GI hemorrhages and post-polypectomy mucosal defect closure. Features 360-degree synchronized tactile torque response and wide jaw aperture designs (up to 16mm).
Engineered for precise endoscopic mucosal resection and submucosal dissection. Cold polypectomy snares utilize ultra-fine braided nitinol filaments for clean guillotine mechanical cuts without thermal electrocautery tissue margins.
Specialized biliary-pancreatic access devices including tip-oriented double and triple-lumen sphincterotomes, radiopaque zebra hydrophilic guidewires with zero-peel PTFE coating, and multi-perforated biliary drainage catheters for stenting pathways.
Advanced continuous-suction negative-pressure ureteral access sheaths (UAS) and helical tipless nitinol stone extraction baskets. Engineered for retrograde intrarenal surgery (RIRS) to control intrarenal pressure while evacuating stone dust.
Protecting expensive video-endoscopes from patient occlusal damage and inner working channel scoring. High-density medical polymer bite blocks with soft strap fixation and non-abrasive dual-ended channel cleaning decontamination brushes.
How our dedicated R&D center solves the mechanical trade-offs between flexibility, kink-resistance, 1:1 torque responsiveness, and biocompatible surface lubrication.
Our stone baskets and cold snares use shape-memory superelastic alloy conditioned at precise austenitic phase transformation temperatures (Af: 10°C - 25°C). Ensures dynamic spring-back after navigating tortuous retroflexed endoscopes without deformation.
Ureteral access sheaths incorporate gradient durometer extrusion (Pebax 72D transition to 40D at the distal tip), reinforced with 304 stainless steel braided coils to prevent lumen collapse under high negative-pressure suction.
Cross-linked polyacrylamide and PVP coatings engineered for ultra-low coefficient of friction (μ < 0.02). Minimizes mucosal shear stress, prevents urothelial trauma, and demonstrates particulate shedding compliant with USP <788>.
Biopsy forceps and endoclip mechanical jaw linkages utilize femtosecond automated laser micro-welding. Tensile joint retention loads consistently exceed 35N, eliminating in-vivo detachment risks during demanding emergency interventions.
| Device Category | Channel Outer Diameter (Fr / mm) | Working Length (mm) | Key Material Specifications | Quality Verification Test Matrix |
|---|---|---|---|---|
| Rotatable Hemoclip | 2.6mm (OD 7.8Fr) | 1650 / 1950 / 2300 | AISI 301 Stainless Steel + PTFE Sheath | 360° Torque Latency, 20N Release Load, 72h In-Vitro Clamping Test |
| Fenestrated Biopsy Forceps | 1.8mm / 2.3mm | 1200 / 1600 / 2300 | Medical 316L SS + Laser-Welded Hinge | Sharpness Profile Cut Test, 40N Pull-Wire Tensile Break Test |
| Cold Polypectomy Snare | 2.4mm | 1800 / 2300 | Braided Fine-Strand Nitinol Cable | Guillotine Shear Efficiency, Dynamic 200-Cycle Actuation Test |
| Suction Ureteral Access Sheath | 10/12Fr, 11/13Fr, 12/14Fr | 350 / 450 / 550 | Co-Extruded Pebax + SS Braided Coil Mesh | Continuous -60kPa Collapse Verification, Urethral Friction Test |
| Zebra Urology Guidewire | 0.032" / 0.035" / 0.038" | 1500 / 2600 / 4500 | Solid Nitinol Core + Hydrophilic Distal Tip | Peeled-Coating Shear Resistance, Radiopaque Fluoroscopy Density |
Global hospital procurement mandates verifiable regulatory assurance. ZHR Med maintains comprehensive Design History Files (DHF) and Device Master Records (DMR) to fast-track regional import registrations.
Importing endoscopic consumables into regulated territories requires precise technical dossier preparation. ZHR Med assists regional partners by providing dedicated technical support: biological evaluation reports (ISO 10993), packaging stability data (ISO 11607 accelerated aging up to 3 and 5 years), and Notified Body-compliant Risk Management files (ISO 14971).
Whether navigating Brazil ANVISA, US 510(k), Saudi SFDA, or Southeast Asian registration portals, our regulatory affairs engineers prepare customized submission files mapped to individual market SKUs.
Direct communication bridges clinical needs and manufacturing tooling. Meet the ZhuoRuiHua engineering and export teams at premier global medical congresses to inspect physical prototypes, verify tolerances, and negotiate custom production schedules:
Direct answers to the most critical technical, regulatory, and logistical inquiries raised by hospital supply chains, distributors, and private-label brand owners.
We manufacture 19 device lines across six clinical tracks: tissue sampling (disposable biopsy forceps, hot biopsy forceps, cytology brushes), mechanical hemostasis (rotatable endoclips, hemoclips), mucosal resection (polypectomy snares, EMR injection needles), ERCP (sphincterotomes, hydrophilic zebra guidewires, biliary drainage catheters), endourology (continuous negative-pressure suction ureteral access sheaths, nitinol stone extractors), and endoscopy reprocessing accessories (bite blocks, cleaning brushes).
We offer comprehensive contract manufacturing solutions. This includes custom handle and grip ergonomics, laser marking of hospital logos or client brands onto sheath surfaces, custom working lengths (e.g., specialized 2300mm enteroscopy lines), unique jaw serration geometries, and complete localized Tyvek blister packaging printed with your registered trademark, language requirements, and GTIN-128 barcodes.
Procurement teams must specify: (1) Minimum endoscope instrument channel internal diameter (e.g., ≥ 2.8mm); (2) Total device working length (e.g., 1650mm for gastroscopy vs. 2300mm for colonoscopy); (3) Distal mechanism style (e.g., fenestrated alligator jaw with/without needle); (4) Desired sterile barrier shelf-life (3-year or 5-year accelerated aging validation); and (5) Regulatory registration scope mandated by your local health authority.
Sterile packaging follows ISO 11607 protocols utilizing medical-grade Tyvek and peelable film. We conduct dye penetration tests, burst pressure tests, and seal peel strength tests on every production shift. Ethylene oxide sterilization strictly complies with ISO 11135:2014, verified through chromatographic gas analysis to ensure Ethylene Oxide (EO) and Ethylene Chlorohydrin (ECH) residues remain well below ISO 10993-7 thresholds.
Consistency is maintained by replacing manual hand-assembly with automated CNC laser cutting, automated wire winding, and multi-cavity precision injection molding tooling. Quality gates are integrated at three stages: raw incoming material spectrometry and tensile inspection, in-process torque/tensile validation, and 100% final optical inspection of mechanical linkages.
Yes. Our internal tooling center designs and fabricates custom injection molds, extrusion dies, and micro-stamping dies. Rapid prototyping via 3D micro-printing and CNC machining delivers functional physical evaluation samples within 15 to 20 working days, backed by a comprehensive Design for Manufacturability (DFM) assessment.
Endourology access devices, mechanical ligation systems, and high-performance cold snares manufactured under ISO 13485:2016 control.
Single-Use Bendable & Continuous Suction Ureteral Access Sheath
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CE Certified Smooth Hydrophilic Ureteral Access Sheath (ISO Verified)
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ODM Disposable Endoscopic Polypectomy Cold Snare with Braided Loop
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Flexible & Navigable Suction Ureteral Access Sheath with Bendable Tip
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Negative Pressure Suction Sheath System for RIRS Kidney Stone Evacuation
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Gastroenterology Rotatable Disposable Hemoclip for Acute Hemostasis
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Hydrophilic Coated Ureteral Access Sheath Introducer Set
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Single-Use Endoscopic Staining & Flushing Spray Catheter
View Technical Data →Contact Jiangxi ZhuoRuiHua Medical Instrument Co., Ltd. directly to discuss clinical trial sampling, custom mold engineering, volume tier pricing, and regulatory technical documentation support.
