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ISO 13485 • CE • US FDA 510(k) Listed Lines

Disposable Medical Device Manufacturer & Global Exporter Since 1994

Infusion, transfusion, dialysis, urology, anaesthesia and surgical single-use devices — produced in a Class 10,000 clean room and shipped to 52+ countries.

Regulatory-Ready Documentation

ISO 13485 QMS, CE technical files, Free Sale Certificates and batch traceability records prepared for importer registration and hospital tenders.

In-House Manufacturing Control

Moulding, extrusion, assembly, printing, ETO sterilisation and QC testing under one roof — no outsourced critical process, no hidden supply chain.

Export Logistics Experience

Over 80% of output is exported. Dedicated export desk handles labelling languages, shipping documents and consolidated container planning.

Who We Are

Three Decades of Hands-On Medical Device Manufacturing in India

Angiplast Private Limited was founded in 1994 in Ahmedabad, Gujarat, and has grown into a vertically integrated manufacturer of single-use medical devices. Our engineers have built tooling, validated sterilisation cycles and scaled production lines for hundreds of device configurations — experience that lets us answer a buyer's technical question in hours, not weeks.

We supply distributors, government health programmes, hospital groups and pharmaceutical brand owners. Devices are sold under our own Angel Touch brand and, equally often, under our partners' labels through OEM and CDMO agreements.

  • Controlled injection moulding area with dedicated product-development personnel
  • Class 10,000 clean room for assembly, pouch sealing and kit packing
  • Captive ethylene oxide (ETO) sterilisation plant with validated cycles
  • In-house laboratory for physical, chemical and biological device testing
  • Approved supplier to leading pharmaceutical and medical device companies
Read Our Company Profile
Angiplast clean room production of disposable medical devices in Ahmedabad, India Established 1994 · Made in India
30+Years of manufacturing experience
52+Export destination countries
300+Device SKUs across 9 therapy areas
80%Of production shipped for export
Product Portfolio

Single-Use Medical Devices by Clinical Application

Nine therapy-focused categories engineered for hospital, dialysis centre and home-care use. Each range is supported by technical drawings, material declarations and sterilisation validation data.

Infusion Therapy

IV infusion sets, burette / measured volume sets, needle-free infusion lines, microbore extension lines, IV cannula and scalp vein sets with precise drop accuracy.

View Infusion Therapy →

Transfusion Therapy

Blood transfusion sets, blood administration sets with filters and blood collection accessories designed for smooth flow and haemolysis control.

View Transfusion Therapy →

Dialysis

Haemodialysis blood tubing sets, AV fistula needles and dialysis accessories manufactured for consistent priming volume and secure connections.

View Dialysis Range →

Gastroenterology

Ryle's tubes, infant feeding tubes, enteral feeding accessories and stomach tubes with clear depth markings and atraumatic distal tips.

View Gastroenterology →

Urology

Foley balloon catheters, urine collection bags, urinemeter with drain bag, male incontinence devices and nelaton catheters.

View Urology Range →

Anaesthesia

Oxygen masks, nebulizer masks, venturi masks, nasal oxygen cannula, ventilator circuits and suction catheters for respiratory care.

View Anaesthesia Range →

Surgery

Wound drainage systems, thoracic drainage catheters, suction sets and surgical disposables for operating theatre and post-operative care.

View Surgery Range →

General Medical Disposable

Everyday consumables that support ward, OPD and emergency workflows — supplied in bulk or hospital-ready pack configurations.

View General Disposables →

Components

Moulded sub-assemblies, roller clamps, spikes, connectors, drip chambers and safety valves for device assemblers and OEM programmes.

View Components →
Production Capability

What Happens Inside Our Facility — Step by Step

Procurement teams audit factories, not brochures. The walkthrough below and the process list show exactly how a device moves from medical-grade resin to a sterile, barcoded pouch.

01

Controlled Injection Moulding

Dedicated moulding area with in-house tool room support for new product development and design changes.

02

Extrusion & Tube Processing

Tubing extrusion, tipping, punching and solvent bonding calibrated to each catheter or line specification.

03

RF Welding & Silk-Screen Printing

High-frequency welding for bags and pouches, plus durable graduation and brand printing.

04

Clean Room Assembly (Class 10,000)

Jig-and-fixture assembly, leak testing and kit packing carried out in a monitored hygienic environment.

05

ETO Sterilisation

Captive ethylene oxide plant with validated cycles, bioburden monitoring and residual verification.

06

In-House QC Laboratory

Dimensional, flow-rate, tensile, leak and sterility-support testing before every batch release.

See Production Facilities

Prefer more detail? Our video library covers individual device assembly, packaging formats and clean-room protocols.

Watch Facility Videos
Quality & Compliance

Certifications and Controls That De-Risk Your Purchase

Every shipment is backed by a documented quality system. Below is what our compliance file contains and why it matters when you register or tender our devices.

ISO 13485

Medical Device QMS

Risk management, design control, supplier qualification and CAPA processes audited against ISO 13485 requirements.

CE Marked

European Conformity

Technical documentation, clinical evaluation summaries and labelling prepared for the applicable CE conformity route.

FDA 510(k)

Selected US-Cleared Lines

Chosen device families hold US FDA 510(k) clearance, evidencing design maturity and testing depth.

Traceability

Lot-Level Records

Resin lot, moulding shift, sterilisation cycle and release data retained for every finished batch.

CDMO & Contract Manufacturing

Build Your Brand on Our Validated Lines

Pharmaceutical companies and device brand owners use Angiplast as an extension of their own operations. We take a concept sketch, an existing competitor sample or a redesign brief and convert it into a validated, sterile, saleable product.

  • Collaborative product design, prototyping, mould design and tool making
  • Speciality expertise in needle-free infusion lines with standard and patented safety valves
  • Respiratory portfolio: oxygen mask, nebulizer mask, venturi mask, ventilator circuit
  • Urology portfolio: urine collection bag, urinemeter with drain bag, incontinence devices
  • Private-label artwork, multilingual IFUs, UDI barcoding and custom kit packing
CDMO / OEM Solutions Contract Manufacturing Services
Angiplast OEM and contract manufacturing of infusion lines and respiratory devices
Global Reach

Supplying Healthcare Systems in More Than 52 Countries

Because most of our volume ships overseas, our documentation, packaging and container planning are built around export realities — not adapted from domestic practice.

Africa

Government health programmes, NGO tenders and regional distributors served with bulk-pack and kit configurations.

Latin America

Portuguese and Spanish labelling, ANVISA-oriented documentation support and consolidated shipments.

Middle East

Long-standing hospital group and importer relationships, with GCC registration document packs.

South & South-East Asia

High-volume infusion and urology supply with short lead times and repeat scheduling.

CIS & Eastern Europe

CE-supported files, Russian-language artwork options and pallet-optimised loading.

Europe & Others

OEM and private-label programmes for brand owners requiring audited, traceable manufacturing.

Meet Us In Person

Upcoming International Trade Exhibitions

Bring your specification sheet to our stand. Our technical and export teams review samples, tooling feasibility and pricing structures on the spot.

MEDICA — Düsseldorf, Germany

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

Arab Health — Dubai, UAE

Dates
9 – 12 February 2026
Location
Stand NP1.E12, Dubai Exhibition Centre

Hospitalar — São Paulo, Brazil

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

WHX Miami — Florida, USA

Dates
17 – 19 June 2026
Location
Stand B-31, Miami Beach Convention Center
Buyer Questions

Frequently Asked Questions from Overseas Purchasers

Answers to the practical questions distributors, importers and brand owners ask before their first order.

Angiplast operates an ISO 13485 certified quality management system. Products carry CE marking under the applicable European conformity route, and selected device families hold US FDA 510(k) clearance. Free Sale Certificates, ISO documentation and product-specific technical files are issued to support importer registration and tender submissions.

OEM and private-label minimum order quantities are defined per device family and typically start at one full production lot per SKU. Artwork, pouch and carton printing, multilingual instructions for use, UDI barcoding and customised kit configurations are all handled in-house by our CDMO team.

Devices are assembled in a Class 10,000 clean room and sterilised in our in-house ethylene oxide plant. Each batch is released against validated sterilisation cycles, bioburden and residual testing, leak and tensile testing, and documented traceability from resin lot to finished pouch.

Yes. We provide the technical dossier elements most authorities request — device master files, material and biocompatibility declarations, sterilisation validation summaries, stability data, plant certificates and notarised or apostilled Free Sale Certificates where required.

Standard catalogue items generally ship within a few weeks of order confirmation, while new OEM tooling programmes follow an agreed development timeline. We handle FOB, CIF and CFR terms, sea and air freight, and pallet or floor-loaded container optimisation to reduce your landed cost per unit.

Ready to discuss your device specification?

Share your drawing, sample or tender requirement. Our technical and export team will respond with feasibility, documentation scope and packaging options.

Contact Angiplast