ISO 13485 & CE Certified Single-Use Dialysis Solutions Engineered for Hospital & Renal Care Procurement
Since 1994, Angiplast Private Limited has been a trusted global OEM manufacturer and direct exporter of single-use medical devices. Our dedicated dialysis portfolio is manufactured in a monitored Class 10,000 cleanroom environment using medical-grade, biocompatible polymers compliant with ISO 10993 testing protocols.
We provide hospital buying groups, renal centres, and overseas distributors with fully validated, ETO sterile dialysis lines that ensure consistent priming volumes, smooth blood handling, and zero leak risk during extracorporeal blood treatment.
Medical-grade PVC blood lines for arterial and venous circulation during hemodialysis. Feature smooth lumen surfaces to prevent hemolysis, integrated pump segments, drip chambers, and universal connectors compatible with leading dialysis machines.
Siliconized, ultra-thin wall stainless steel needles designed for smooth vascular access with minimal tissue trauma. Available in fixed and rotating wing configurations with back-eye options to optimize blood flow during hemodialysis sessions.
High-capacity sterile fluid collection and drainage bags designed for peritoneal dialysis and renal fluid discharge. Precision high-frequency RF welding guarantees leak-proof containment and clear dual volumetric graduations.
Our dialysis portfolio is backed by complete technical construction files (TCF), material declarations, and international regulatory clearance to streamline product registration and tender bidding in importer territories.
| Product Line | Key Material / Construction | Compliance & Certifications | Sterilisation & Packaging |
|---|---|---|---|
| Hemodialysis Blood Tubing Set | Medical PVC / DEHP-Free options, non-kinking flexible tubing, acrylic drip chambers | ISO 13485, CE Marked, ISO 8637-2 Compliant, FSC Issued | ETO Sterilised, Pyrogen-Free, Medical-grade blister pouch, 1 set/pouch |
| AV Fistula Needle Set | AISI 304 Stainless Steel, Siliconized needle tip, PVC tubing, ABS wing hub | ISO 13485, CE Marked, Biocompatibility Tested (ISO 10993) | Individual Peel Pack, ETO Sterile, 50 pcs/inner box |
| Peritoneal Fluid Drain Bag | Medical PVC film, High-Frequency welded seams, Non-toxic drainage tube | ISO 13485, CE Class I/IIa, Free Sale Certificate | Sterile, Single-use PE pouch, Bulk master carton loading |
Angiplast serves as a high-capacity contract manufacturing partner (CDMO/OEM) for global pharmaceutical and medical supply companies. We engineer customized blood tubing set configurations and peritoneal kits tailored to your target dialysis equipment brands and local market specifications.
Class 10,000 Cleanroom Production
Key information for international hospital procurement managers, medical importers, and distributor networks.
Yes. Our blood tubing sets are designed with standard pump segments and universal luer-lock connectors compatible with leading hemodialysis machines used worldwide, including Fresenius, Gambro, Nipro, B. Braun, and Nikiso equipment.
We supply AV Fistula Needles in 15G, 16G, and 17G sizes with standard needle lengths (1 inch and 1.25 inch). Importers can choose between fixed wings or rotating wings, as well as configurations with or without back-eye orifices.
We supply complete registration dossiers including ISO 13485 QMS certificates, CE technical file summaries, biocompatibility reports, ETO sterilisation validation reports, shelf-life stability test data, and notarized Free Sale Certificates (FSC).
Private-label MOQs are based on standard production lot runs per SKU (typically 10,000 to 20,000 units depending on custom printing and packaging requirements). Our export desk works with buyers to consolidate container shipments efficiently.
Speak directly with our export engineering desk to review custom blood tubing configurations, sample requests, and annual tender pricing.
