Infusion & Needle-Free Lines
Custom IV sets, microbore extension lines, burette sets, and needle-free infusion valves with standard or patented safety mechanisms.
Turnkey Medical Device CDMO
Precision Contract Manufacturing to Global Regulatory Standards
At Angiplast Pvt. Ltd., we serve as an audited Original Equipment Manufacturer (OEM) and Contract Development & Manufacturing Organisation (CDMO) for international pharmaceutical leaders, hospital supply networks, and medical device distributors across 52+ countries.
With three decades of continuous manufacturing expertise since 1994, our vertically integrated plant in Gujarat, India, de-risks medical device sourcing. We convert conceptual product specifications, 3D CAD models, or legacy product blueprints into market-ready, ISO 13485-compliant sterile medical disposables.
- Strict non-disclosure agreements (NDA) safeguarding partner IP
- Custom mold design, tooling fabrication, and rapid prototyping
- Cleanroom manufacturing in certified Class 10,000 (ISO Class 7) facilities
- Turnkey packaging, UDI barcoding, and multilingual labeling
- Full technical dossier support for CE Marking & US FDA 510(k) filings
Proven OEM Partner to Global Healthcare Leaders
We are privileged to manufacture custom components, specialized infusion systems, and private-label medical kits for renowned multinational pharmaceutical organizations including:
End-to-End CDMO Services
Integrated Engineering & Manufacturing Capabilities
Our complete in-house setup eliminates third-party dependencies, guaranteeing complete batch traceability, rigorous quality assurance, and competitive unit economics.
01
Custom Tooling & Moulding
In-house tool room equipped for precision CNC machining, custom core-pin fabrication, and multi-cavity injection moulding of medical-grade polymers (PVC, PP, ABS, PC, TPU).
02
Precision Tubing Extrusion
High-speed extrusion lines producing kink-resistant, DEHP-free, and non-PVC medical tubing calibrated for strict outer/inner diameter tolerances and flow rates.
03
RF Welding & Printing
High-frequency radio welding for leak-free liquid bags and drainage systems, accompanied by non-toxic, high-precision graduation and logo printing.
04
Class 10,000 Cleanroom
Assembly, ultrasonic solvent bonding, tipping, punching, and jig-assisted fitting executed inside controlled Class 10,000 (ISO Class 7) cleanroom environments.
05
In-House ETO Sterilisation
Captive Ethylene Oxide (ETO) sterilisation chambers validated under ISO 11135 standard cycles, supported by residual aeration and bioburden analysis.
06
In-House QC Testing Lab
Comprehensive physical, mechanical, chemical, bioburden, and toxicity testing performed on every production lot prior to release.
Custom Production Scope
Device Portfolios Available for OEM & Private Label
We offer standard, modified, or completely customized production lines across major single-use medical device categories.
Respiratory & Anaesthesia Care
Oxygen masks, high-efficiency nebulizer kits, venturi masks, nasal cannulas, and custom breathing circuits engineered for clinical accuracy.
Urology & Fluid Management
Urine drainage bags, closed-system urinemeters, Foley catheters, and specialized collection kits featuring anti-reflux valves.
Gastroenterology Disposables
Enteral feeding tubes, Ryle's tubes, and stomach irrigation lines with radiopaque stripes and non-traumatic tip configurations.
Dialysis & Blood Lines
Haemodialysis blood tubing sets, AV fistula needle sets, and blood transfusion accessories manufactured with high biocompatibility.
Moulded Sub-Assemblies
Custom spikes, drip chambers, roller clamps, luer locks, injection sites, and manifold valves supplied to medical assembly facilities worldwide.
Technical Compliance & OEM Standards
Frequently Asked Questions by Overseas Procurement Teams
Key technical, quality assurance, and project execution details for international buyers and pharmaceutical contract managers.
What regulatory approvals and certificates support your CDMO / OEM projects?
Angiplast operates under an ISO 13485 certified Quality Management System. Our product lines carry European CE marking, and selected device lines possess US FDA 510(k) clearance. For private-label partners, we compile comprehensive technical files, biocompatibility reports (ISO 10993), stability studies, and Free Sale Certificates (FSC) to facilitate local importer registration.
How do you protect partner IP and proprietary product designs?
Intellectual Property security is fundamental to our contract manufacturing agreements. We execute legally binding Non-Disclosure Agreements (NDAs) prior to receiving drawings or samples. Tooling created for partner projects is customer-owned, strictly catalogued, and utilized exclusively for authorized production runs.
What packaging and private-label customization options are available?
We offer full private-label packaging support, including custom blister packaging, medical pouch sealing, multi-color outer carton printing, multilingual Instructions for Use (IFUs), and Unique Device Identification (UDI) barcoding compliant with EU MDR and US FDA regulations.
What is the typical timeline for new medical device tooling & validation?
Standard OEM modifications on existing components can be prototyped within 2 to 4 weeks. Full custom mold creation, sample moulding, bioburden testing, and sterilisation cycle validation typically take 8 to 14 weeks depending on device complexity.
Discuss Your Custom Device Project with Our Engineers
Whether you need contract manufacturing for a new patent, private-label branding on established devices, or custom injection moulding in India, our technical team is ready to evaluate your specifications.