Infusion & Extension Lines
Custom OEM manufacturing for standard IV infusion sets, needle-free infusion lines with patented safety valves, microbore extension lines, pressure monitoring lines, and measured volume burette sets.
ISO 13485 • CE • US FDA 510(k) Compliant Facilities
Contract Manufacturing & Services
End-to-End CDMO and OEM Medical Disposable Device Manufacturing for Global Healthcare Brands
Turnkey CDMO & OEM Expertise
Precision Medical Device Contract Manufacturing in India
Angiplast Private Limited is a specialized contract manufacturer of single-use medical disposables, component assemblies, and turnkey medical systems. Established in 1994, we provide global pharmaceutical companies, brand owners, and OEM partners with end-to-end contract manufacturing services backed by 30+ years of technical precision.
Our infrastructure encompasses medical-grade polymer extrusion, high-speed injection moulding, Class 10,000 cleanroom assembly, ETO sterilisation, and full regulatory packaging. We take custom medical devices from conceptual drawings or legacy redesigns to fully validated, market-ready commercial products.
- Specialised OEM capability in needle-free infusion systems with standard & patented safety valves
- Class 10,000 cleanroom facility for assembly, packaging, and micro-fluidic testing
- Captive ethylene oxide (ETO) gas sterilisation with validated cycles
- ISO 13485 QMS and US FDA 21 CFR Part 820 compliant manufacturing protocols
- In-house analytical laboratory for bioburden, pyrogen, toxicity, and chemical testing
ISO 13485 Certified · Exporting to 52+ Countries
30+Years of OEM & CDMO Engineering Experience
100%In-House Quality Control & Traceability
Class 10kCertified Cleanroom Production Environment
80%+Exported Volume to Global Brand Owners
Core Expertise
Key Contract Manufacturing Product Lines
We work with international medical technology companies to manufacture high-precision disposables engineered to exact product specifications and regulatory standards.
Respiratory & Anaesthesia Devices
Precision manufacturing of oxygen masks, nebulizer masks, venturi masks, nasal oxygen cannulas, ventilator circuits, and custom breathing accessories for critical care environments.
Urology & Drainage Solutions
Contract production of urine collection bags, urinemeters with integrated drain bags, male incontinence devices, Foley balloon catheters, and closed wound drainage systems.
Integrated Infrastructure
End-to-End Contract Manufacturing Capabilities
By keeping every phase of manufacturing in-house, Angiplast guarantees maximum cost efficiency, strict quality compliance, and rapid time-to-market for contract projects.
01
Controlled Injection Moulding
Tooling design support and precision moulding using medical-grade polymers (PVC, PP, ABS, PC, DEHP-free materials).
02
Precision Tubing Extrusion
High-speed extrusion lines dedicated to medical-grade tubing with calibrated wall thickness, diameter, and kink resistance.
03
RF Welding & Printing
High-frequency radio welding for medical collection bags and cleanroom silk-screen printing for clear graduation scales.
04
Class 10,000 Cleanroom Assembly
Solvent bonding, tipping, punching, micro-assembly, and 100% leak testing executed with custom jigs and fixtures.
05
Automated Blister & Poly Packaging
Automated pouch sealing, thermoformed blister packaging, unit pouch barcoding, and customized master carton packing.
06
Captive ETO Sterilisation & Lab QC
In-house ethylene oxide sterilisation plant with full parametric batch validation, pyrogen, toxicity, and sterility testing.
Global Quality Standards
Regulatory Compliance & Quality Approvals
Our quality control and quality assurance framework operates under ISO 13485 standards and aligns strictly with US FDA 21 CFR Part 820 requirements.
ISO 13485:2016
Medical QMS Certified
Comprehensive Quality Management System covering product design, component manufacturing, risk management, cleanroom assembly, and post-market surveillance.
CE Marking
European Conformity
Complete technical files, risk assessment dossiers, biological evaluation reports, and CE certificates supporting smooth importation into EU countries.
US FDA 510(k)
Cleared Product Lines
Selected device portfolios carry US FDA 510(k) clearance, demonstrating mature design validation, biological safety, and testing rigor.
Strategic Sourcing Advantage
Unrivaled Cost Efficiency for International OEM Partners
Partnering with Angiplast allows medical brand owners and distributors to optimize production costs without incurring capital expenditure for factory infrastructure or regulatory maintenance.
- Leverage Existing Infrastructure: Access state-of-the-art moulding, extrusion, and cleanroom facilities without setup costs.
- Engineering & Prototyping Support: Collaborative tooling design, prototyping, process validation, stability testing, and biocompatibility studies.
- Private Label Flexibility: Customized packaging options including multilingual artwork, UDI barcoding, and private-label pouch printing.
- Streamlined Supply Chain: In-house export desk managing global shipping documentation, pallet optimization, and customs clearance support.
Ready to Discuss Your Contract Manufacturing Project?
Share your technical drawings, sample specifications, or volume requirements with our engineering team for an accurate feasibility report and quote.