Tianck Medical FAQ - Tianck Medical

20+

Years of OEM/ODM Experience

CE / ISO

Certified Quality Systems

50+

Exporting Countries & Regions

100%

Sterilized Medical-Grade Quality

Tianck Medical FAQ & Knowledge Base

Explore detailed information regarding product registration, clinical usage, safety protocols, and supply chain logistics.

1. Registration, Certifications & Regulatory Qualifications

What certifications does Tianck Medical hold for international markets?

Tianck Medical is an ISO 13485 certified manufacturer of high-end medical consumables. Our key product lines, including Interventional Cardiology accessories, Guidewires, Urology drainage sets, and Dialysis catheters, carry the CE mark (Conformité Européenne), signifying compliance with the European Medical Devices Regulation (MDR). Additionally, we maintain GMP compliance, and our manufacturing facilities undergo routine audits to ensure consistent adherence to international quality management systems. We also possess Free Sales Certificates (FSC) to facilitate seamless custom clearance in various Asian, African, and South American markets.

Does Tianck Medical support local product registration for distributors?

Yes, we offer comprehensive regulatory support to our global distribution partners. Our dedicated regulatory affairs team compiles and provides complete technical documentation dossiers, including Certificate of Analysis (CoA), sterilization validation reports (EO sterilization process records), biocompatibility testing data, clinical evaluation reports, and manufacturing flowcharts. We work closely with local ministries of health and drug administrations to help our partners acquire local import registration certificates quickly and efficiently.

What is the validity and scope of your medical device production license?

Tianck Medical operates under a valid Class II and Class III Medical Device Production License issued by the National Medical Products Administration (NMPA). Our production capabilities cover extrusion, molding, assembly, packaging, and sterilization within state-of-the-art Class 100,000 (ISO Class 8) cleanrooms. The scope of our production license covers all primary products listed on our catalog, assuring that every device is manufactured under strict legal and sanitary frameworks.

2. Clinical Indications, Contraindications & Operation

What are the primary indications and clinical applications of PTA and PTCA Balloon Dilatation Catheters?

Our PTCA (Percutaneous Transluminal Coronary Angioplasty) Balloon Dilatation Catheters are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. Our PTA (Percutaneous Transluminal Angioplasty) Balloon Dilatation Catheters are designed for peripheral vascular interventions, including iliac, femoral, popliteal, and renal arteries, to treat atherosclerotic obstructive lesions and restore arterial blood flow.

What are the contraindications for using PTFE and Hydrophilic Coated Guidewires?

Tianck guidewires should not be used in patients with known hypersensitivity to the materials of the guidewire, including PTFE (polytetrafluoroethylene), hydrophilic coatings, or nitinol/stainless steel alloys. They are contraindicated in total vessel occlusions that cannot be crossed by standard interventional techniques, or in settings where acute vessel rupture, severe calcification, or unstable thrombi pose an unacceptable risk of embolization or perforation.

What precautions must be observed during the placement of Ureteral Stents?

During the insertion of a Ureteral Stent (Double J Stent), operators must use fluoroscopic or endoscopic visualization to ensure correct placement in the renal pelvis and bladder. Avoid excessive force during advancement to prevent ureteral perforation or mucosal stripping. Ensure the stent length matches the patient's anatomy to prevent migration or severe bladder irritation. Stents must not be left indwelling beyond their recommended clinical lifespan (typically up to 3 to 6 months depending on the specific model and material grade) to avoid encrustation and subsequent removal difficulties.

How should the Balloon Inflation Device (B Type) be prepared and operated?

The Balloon Inflation Device (B Type, up to 40 atm) must be primed with a sterile contrast medium mixture (usually 50:50 contrast and saline) before connection to the balloon catheter. To prevent air embolism, ensure all air bubbles are completely purged from the syringe cylinder and extension tubing. During inflation, monitor the pressure gauge constantly. Do not exceed the Rated Burst Pressure (RBP) of the dilatation balloon catheter being inflated.

3. Safety, Sterilization & Adverse Event Management

What are the potential adverse events associated with vascular catheterization?

Potential adverse events associated with vascular catheterization include, but are not limited to: local hematoma or hemorrhage at the puncture site, vessel spasm, thrombosis, distal embolism, arterial dissection or perforation, infection/sepsis, allergic reaction to contrast media, and cardiac arrhythmias. Immediate access to emergency surgical or interventional rescue options must be maintained during all procedures.

What is the protocol for handling and reporting a suspected device malfunction?

If a device malfunction or adverse event occurs during a procedure: 1. Immediately secure patient safety according to standard hospital protocols. 2. Retain the suspect device, its packaging, and all associated accessories. Do not discard or clean the device, as it may contain evidence critical for root-cause analysis. 3. Note the product model, lot/batch number, and specific details of the incident. 4. Contact your local distributor or Tianck Medical's quality assurance department within 24 hours. We will initiate a formal investigation and provide corrective action reports.

Are Tianck Medical products reusable? What is the sterilization standard?

No, all Tianck Medical catheterization, guidewire, and urology drainage products are strictly designated for **Single Use Only**. Reusing these devices poses critical risks of cross-contamination, pyrogenic reactions, and structural degradation that can lead to device failure in vivo. All products are sterilized using Ethylene Oxide (EO) gas, achieving a Sterility Assurance Level (SAL) of 10^-6. Do not use if the sterile barrier packaging is opened, damaged, or wet.

4. Procurement, Distribution, Pricing & Supply Chain

How does Tianck Medical manage pricing and global distribution agreements?

We offer competitive tiered pricing structures based on order volume, regional market potential, and partnership type (exclusive vs. non-exclusive distribution). To protect our local partners, we maintain a strict pricing policy that prevents cross-border dumping. For detailed quotations, please submit an inquiry with your expected annual volumes and target market details.

What are the lead times and shipping options for bulk international orders?

For standard catalog configurations, our manufacturing lead time ranges between 30 to 45 days upon receipt of down payment. Custom OEM/ODM orders require additional validation and may take 60 to 90 days. We ship globally via sea freight, air cargo, or express couriers (DHL/FedEx/TNT) depending on the urgency and volume. All shipments are packed in heavy-duty double-walled corrugated cartons with internal moisture protection to ensure pristine condition upon arrival.

Does Tianck Medical participate in national tenders or hospital listing programs?

Yes, we actively support our regional distributors in bidding for government procurement tenders and local hospital listing programs. We provide tailored authorization letters, manufacturer declaration statements, price support strategies, and customized packaging labels if requested by specific health authorities. Our extensive experience in international tenders ensures all documentation meets rigorous compliance standards.

Our Core Product Portfolio

Explore our highly certified medical consumables developed for global clinical applications.

20 Years of Clinical Innovation

About Tianck Medical CO., LTD

Tianck Medical CO., LTD is a professional medical devices manufacturer dedicated to R&D, production, and sales. We keep a sustained research & development strategy and have achieved excellent results in the field. Tianck Medical strives to improve patient care by providing high-quality products at reasonable prices.

Our production lines cover Interventional Cardiology, Urology, Dialysis, Anaesthesia, and Nursing Care. Key products include high-performance guidewires, introducer sheaths, balloon inflation devices, drainage catheters, hemodialysis catheters, ureteral stents, and disposable pressure transducers. Our products are exported to Europe, Asia, South America, Oceania, and Africa.

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