Sales: +91 9099 928 652 [email protected] Mon – Sat : 10:00 AM – 07:00 PM (IST)
ISO 13485 & CE Certified Manufacturer

Company History & Profile

Three Decades of Healthcare Disposable Manufacturing Excellence & Global Export Services

About Angiplast Private Limited

World-Class Disposable Medical Device Manufacturer in India

Founded in 1994, Angiplast Private Limited has established itself as an industry-leading manufacturer and international exporter of single-use medical devices and healthcare disposables. Operating from a state-of-the-art facility in Kheda, Gujarat, India, our manufacturing infrastructure is engineered to deliver zero-defect disposables for hospitals, dialysis centers, operating theaters, and medical distributors worldwide.

Over the past 30+ years, Angiplast has combined advanced polymer processing technologies with rigorous quality management systems compliant with ISO 13485:2016 standards. All product lines hold CE markings under European regulations, and key medical device lines carry US FDA 510(k) clearances. We proudly serve hospital supply networks and global pharmaceutical companies under our proprietary brand Angel Touch and through custom OEM / CDMO contract manufacturing.

  • Controlled plastic injection moulding facility backed by an in-house toolroom and R&D team
  • Monitored Class 10,000 (ISO Class 7) Cleanroom for medical assembly and primary pouch sealing
  • Captive Ethylene Oxide (ETO) sterilisation plant running validated exposure cycles
  • In-house physical, chemical, leak-integrity, bioburden, and sterility testing laboratory
  • Export footprint spanning healthcare institutions across 52+ countries worldwide
Angiplast Class 10000 cleanroom medical device assembly facility Established 1994 · ISO 13485 & CE Certified
30+Years of Industry Leadership
52+Export Destination Nations
300+Global Importers & Distributors
300+Skilled Cleanroom & QC Specialists
Executive Leadership

Experienced Management & Technical Personnel

Angiplast Private Limited operates under a professional management structure led by Managing Director Ashit B. Shah, who brings over two decades of technical expertise and commercial vision to the medical device manufacturing sector.

Our operational management encompasses dedicated department leads across Polymer Tooling, Cleanroom Production, Regulatory Compliance, Quality Assurance, and International Trade. With a total workforce exceeding 300 skilled technicians, engineers, and quality assurance personnel, Angiplast delivers continuous production capacity to meet stringent hospital supply schedules.

Quality Policy & Mission

Uncompromised Safety & Customer Trust

Our core mission is to provide global healthcare providers with safe, high-precision, and reliable disposable medical devices at competitive commercial terms. Quality policy compliance is integrated into every stage of procurement, moulding, assembly, packaging, and final ETO sterilisation.

Every product lot undergoes rigorous batch release protocol verification, complete with material compliance records, leak-testing certificates, residual EO level monitoring, and sterilisation indicator validations tailored to international regulatory standards.

In-House Production Power

Comprehensive Manufacturing Capabilities

Our facility integrates all critical manufacturing operations under one roof, ensuring absolute quality control, product traceability, and confidential OEM production.

01

Precision Injection Moulding

High-volume controlled moulding bays equipped with automated tooling for micro-sized medical components, valves, and connectors.

02

Extrusion & Secondary Tubing Operations

Medical-grade PVC, DEHP-free, and TPU tubing extrusion featuring automated tipping, punching, micro-hole drilling, and solvent bonding.

03

High-Frequency RF Welding

Precision RF welding for urine collection bags, drainage bags, and specialty fluid containers with durable silk-screen volume graduations.

04

Class 10,000 (ISO 7) Cleanroom Assembly

Hygienic assembly lines with ergonomic jigs, multi-point leak testing, blister pouch sealing, and customized kit packing.

05

Ethylene Oxide (ETO) Sterilisation

Captive ETO sterilisation chambers running fully automated and validated cycles according to EN ISO 11135 specifications.

06

In-House Testing Laboratory

Comprehensive physical, tensile, flow rate, burst pressure, leak, bioburden, and sterility testing performed on every production lot.

Clinical Categories

Therapy-Focused Single-Use Medical Disposables

Our catalogue covers over 300 product SKUs manufactured for critical healthcare applications, available under private label or our Angel Touch brand.

Infusion Therapy

IV infusion sets, measured volume burette sets, needle-free extension lines, IV cannulas, microbore extension sets, and flow regulators.

Transfusion Therapy

Blood transfusion sets, administration sets with 200-micron filters, blood collection accessories, and micro-drip blood tubing.

Dialysis Disposables

Haemodialysis blood tubing sets, AV fistula needles, transducer protectors, and custom renal care accessory lines.

Gastroenterology

Enteral feeding bags, Ryle's nasogastric tubes, infant feeding tubes, and stomach tubes engineered with smooth atraumatic distal eyes.

Urology Care

2-way and 3-way silicone Foley balloon catheters, urine collection bags, precision urinemeters with drain bags, and Nelaton catheters.

Anaesthesia & Respiratory

Oxygen masks, high-concentration nebulizer masks, venturi masks, nasal oxygen cannulas, suction catheters, and ventilator breathing circuits.

Surgical Disposables

Closed wound suction drainage units, thoracic drainage catheters, Yankauer suction sets, and abdominal drainage lines.

General Disposables

Rectal tubes, umbilical cord clamps, infant mucus extractors, and hospital consumables packaged for ward and emergency room workflows.

OEM Medical Components

Moulded spikes, drip chambers, roller clamps, needle-free valves, male/female luer locks, and stopcocks for device assemblers.

Global Footprint

Upcoming Medical Trade Exhibitions

Angiplast regularly exhibits at leading international medical trade shows. We invite procurement teams, importers, and brand owners to meet our executive team in person.

MEDICA — Düsseldorf, Germany

Event Dates
17 – 20 November 2025
Booth Location
Hall 07, Stand E24

WHX Dubai (Arab Health) — UAE

Event Dates
09 – 12 February 2026
Booth Location
Stand NP1.E12, Dubai Exhibition Center

Hospitalar — São Paulo, Brazil

Event Dates
21 – 24 May 2024
Booth Location
Booth D-279, São Paulo Expo

WHX Miami (FIME) — Florida, USA

Event Dates
17 – 19 June 2026
Booth Location
Stand B-31, Miami Beach Convention Center
Frequently Asked Questions

Information for International Procurement Officers

Direct answers to common questions regarding regulatory compliance, OEM contract terms, and export shipping logistics.

Angiplast operates under an ISO 13485:2016 certified Quality Management System. Our product technical files are CE marked in compliance with applicable European Directives and Medical Device Regulations. Additionally, select product lines hold US FDA 510(k) clearances, and we provide Free Sale Certificates (FSC) to facilitate fast importer registration.

Yes. OEM and CDMO contract manufacturing represent a core part of our business. We collaborate with pharmaceutical firms and medical device brand owners worldwide to provide custom plastic moulding, automated tube extrusion, cleanroom assembly, validated ETO sterilisation, artwork design, multilingual IFU creation, and UDI barcoding.

All critical device handling, assembly, and pouch sealing occur within our Class 10,000 (ISO Class 7) Cleanroom environment. Every batch is released after undergoing physical, mechanical, bioburden, residual EO, and sterility validation tests in our in-house laboratory.

More than 80% of our production is exported to over 52 countries across Europe, Latin America, the Middle East, Africa, and Asia. Our export team manages multilingual packaging, Apostilled Free Sale Certificates, Certificate of Analysis (COA) for every shipment, freight consolidation, and FOB/CIF delivery terms.

Partner with an ISO 13485 Certified Medical Manufacturer

Submit your product specifications, OEM requirements, or tender inquiries to receive technical data sheets, sample kits, and direct factory pricing.

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