Precision-crafted ERCP instruments engineered for complex choledocholithiasis management in accordance with Saudi Food and Drug Authority (SFDA) technical regulations.
Navigating the intersection of rapid epidemiologic shifts, the Health Sector Transformation Program, and stringent SFDA regulatory controls for Endoscopic Retrograde Cholangiopancreatography (ERCP).
The Kingdom of Saudi Arabia faces elevated rates of gallbladder diseases, cholelithiasis, and secondary biliary lithiasis, accelerated by lifestyle changes, genetic markers, and metabolic syndromes. Regional specialized surgical centers across Riyadh, Jeddah, and the Eastern Province witness an ever-expanding volume of therapeutic ERCP procedures requiring high-torque extraction baskets.
Centralized procurement through the National Unified Procurement Company (NUPCO) requires international medical device manufacturers to maintain uncompromising consistency, unyielding lot traceability, and substantial price efficiency. Hospital clusters operating under the Ministry of Health (MOH) insist on reliable consumable suppliers with verified CE certification and established registration readiness.
The Saudi Food & Drug Authority (SFDA) enforces stringent technical documentation requirements under the Medical Device Marketing Authorization (MDMA) pathways. Endoscopy accessories entering KSA must show full compliance with MDR (EU) 2017/745, rigorous biological evaluation via ISO 10993, and verifiable sterile barrier validation following ISO 11607 standards.
How advanced shape-memory alloy metallurgical processing resolves common clinical intraoperative challenges: wire collapse, traumatic mucosal friction, and basket entrapment.
Our baskets feature medical-grade superelastic nickel-titanium (Nitinol) wires treated with advanced vacuum heat-forming protocols. Even after dynamic multi-cycle deployment inside tortuous distal bile ducts or strictures, the basket snaps back to its engineered geometry without kinking or residual mechanical fatigue, maximizing calculus capture efficiency.
Constructed with medical-grade multi-layer PTFE and polyimide extrusions, the outer delivery catheter features a ultra-low friction coefficient. The coaxial lumen layout permits continuous radiopaque contrast injection during real-time fluoroscopy, enabling Saudi surgical teams to assess clearance without removing the basket assembly.
Addressing the clinical fear of calculus impaction, our heavy-duty baskets feature an reinforced proximal swaged connector compatible with emergency lithotripsy handles. Should a dense calculus become incarcerated in the ampulla, traction can be applied to fragment the stone without endoscopic sheath shearing.
| Basket Configuration | Wire Structure | Working Length / Outer Diameter | Primary Clinical Indication | Radiopaque Markers |
|---|---|---|---|---|
| Helical 4-Wire Biliary | Nitinol Superelastic (0.28mm wire) | 1950mm / 1.8mm – 2.3mm Fr | Small to medium common bile duct stones, sludge sweep | Dual Platinum-Iridium Markers |
| Diamond Shaped Extraction | 4-Wire High-Radial Force Braided | 1950mm / 2.3mm Fr | Impacted single calculus, hard papillary or cystic duct stones | Distal Atraumatic Bullet Tip Marker |
| Rotatable Oval Basket | Spiral Shape Memory Nitinol | 2000mm / 1.8mm Fr | Intrahepatic duct branching, complex anatomical angles | Tri-band fluoroscopy indicators |
| Endourology Stone Extractor | TiNi Micro-wire (Tipless 3/4-wire) | 1150mm / 1.5Fr – 2.2Fr | Renal pelvic, calyceal, and lower ureteral calculi retrieval | Laser-welded Gold Marker Collar |
By integrating automated micro-crimping, optical non-contact laser measurement, and cleanroom 100,000 protocols, we provide consistent quality at predictable scales.
Manual basket assembly introduces variable wire tension, leading to asymmetric basket opening inside the duodenum. Our Class 100,000 cleanroom production line employs micro-robotic automated tension fixtures ensuring 100% radial symmetry and uniform deployment forces across all production lots.
The critical junction between the basket wire and the operating pull cable is joined using precision pulsed laser welding under an argon protective shield. This completely eliminates micro-oxidation, guaranteeing high tensile integrity exceeding 80 Newtons—preventing detachment failures under heavy surgical load.
Every single device is marked with a laser-etched UDI (Unique Device Identifier). Supported by an enterprise Manufacturing Execution System (MES), our factory maps every basket directly back to incoming raw nitinol wire mill certs, ethylene oxide (EO) sterilization cycle data, and dimensional QC logs.
Streamlined collaboration for Saudi medical distributors, authorized representatives, and procurement officers bidding on public and private healthcare tenders.
We provide Saudi importers and Authorized Representatives (AR) with comprehensive technical documentation in Summary Technical Documentation (STED) format, including ISO 11135 EO sterilization residual reports, aging study validations (3-year shelf-life), risk management files per ISO 14971, and biocompatibility documentation (ISO 10993-1/-4/-5/-7/-10/-11).
Labels and Instructions for Use (IFU) are supplied compliant with SFDA language guidelines, integrating clear dual Arabic and English typography, GMDN/EMDN nomenclature, GS1 DataMatrix barcodes with GTINs, explicit expiration dates, and sterile barrier symbology according to ISO 15223-1.
Experienced shipping lanes provide direct cold-chain and temperature-monitored international air cargo delivery straight into King Khalid International Airport (RUH) and King Abdulaziz International Airport (JED). We work seamlessly with your freight forwarders, handling SASO/SABER declarations and customs clearance manifests without operational friction.
Key information covering device certification, SFDA pathways, OEM customization, and localized supply parameters.
Explore our CE-approved portfolio engineered for modern GI endoscopy suites, surgical centers, and endourology theatres across Saudi Arabia and the Middle East.
Equip your healthcare distribution network across Saudi Arabia, GCC nations, and global clinical accounts with precision CE-marked instruments direct from our digital smart facility.
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