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ISO 13485 • CE MARKED • ETO STERILE

Urology Disposable Medical Devices & Urinary Drainage Systems

Manufacturer & Global Supplier of Sterile Foley Catheters, Urometers, Urine Drainage Bags & TUR Irrigation Sets.

Clinical Precision & Safety

CE & ISO Certified Disposable Urology Products Manufacturer

Angiplast Private Limited is a trusted Indian manufacturer and international exporter of single-use urology medical disposables. Produced in a Class 10,000 cleanroom environment using medical-grade PVC, latex, and 100% biocompatible silicone, our urology product line delivers optimum trauma-free insertion, leak-proof closed drainage, and accurate volume measurement for intensive care and surgical workflows.

Urometer Precise Urine Volume Meter with Drainage Bag

Urometer (Urine Meter System)

Engineered for precise hourly monitoring of urinary output in ICU, critical care, and post-operative recovery settings.

  • 500ml clear measured chamber with 1ml & 5ml graduations
  • 2000ml overflow drainage bag with top T-valve outlet
  • Kink-resistant 120cm inlet tube with needle-free sampling port
  • Hydrophobic bacterial filter for closed system contamination prevention
Latex Foley Balloon Catheter 2-Way and 3-Way

Latex Foley Balloon Catheters

Flexible 2-Way and 3-Way catheters designed for smooth urethral insertion and secure intra-vesical retention.

  • Silicone-coated natural latex construction to minimize encrustation
  • Symmetrical balloon capacity (5ml to 30ml) ensuring secure positioning
  • Color-coded hard plastic valve for accurate size identification (Fr 06 to Fr 24)
  • Smooth eyelets and distal tip for trauma-free catheterization
100% Silicone Foley Balloon Catheter

100% Silicone Foley Catheter

Biocompatible, non-allergenic all-silicone catheter for long-term catheterization and latex-sensitive patients.

  • 100% medical-grade translucent silicone shaft for clear visualization
  • Radiopaque line throughout the length for X-ray verification
  • Maximum lumen diameter to reduce tissue irritation and calculus formation
  • Available in 2-Way and 3-Way variants with color-coded inflation port
Disposable Urine Collection Bag 2000ml

Disposable Urine Collection Bag

Closed urinary drainage bag equipped with non-return anti-reflux valve for standard hospital drainage.

  • Standard 2000ml capacity with clear scale graduations
  • Reinforced eyelets for stable bedpost hanging
  • Non-return valve prevents retrograde urinary infection
  • Bottom T-valve or push-pull drain valve options
Ambulatory Urine Leg Bag with Straps

Urine Leg Bag (Ambulatory)

Discreet and comfortable leg drainage bag designed for mobile patients managing urinary incontinence.

  • Available capacities: 500ml and 750ml
  • Soft non-woven fabric backing reduces skin moisture and friction
  • Adjustable elastic fabric straps for secure thigh or calf attachment
  • Kink-resistant inlet tube customizable in short or long lengths
TUR Irrigation Set Y-Junction Tubing

TUR Irrigation Set ('Y'-Junction Set)

High-flow irrigation tubing set specifically configured for Transurethral Resection of the Prostate (TURP) procedures.

  • Dual-spike 'Y'-junction setup for continuous fluid container switching
  • Wide bore PVC tubing delivering maximum flow rate without collapse
  • Precision roller clamps for effortless fluid adjustment
  • Universal stepless male luer lock connector for endoscope hookup
Sterile Nelaton Catheter for Intermittent Catheterization

Nelaton Catheter

Unballooned, single-use catheter designed for short-term bladder evacuation and intermittent catheterization.

  • Medical-grade thermo-sensitive PVC softens upon body insertion
  • Closed round distal tip with two lateral eyes for optimal drainage
  • Color-coded funnel connector for instant size recognition (Fr 06 - Fr 20)
  • Universal 40cm length (Male/Standard) and 20cm (Female) options
External Male Condom Catheter Latex Sheath

External Male Condom Catheter

Non-invasive external drainage sheath for male patients suffering from involuntary urinary leakage.

  • 100% natural latex roll for skin-friendly custom fitting
  • Adhesive foam strip included for secure non-constricting hold
  • Extended funnel connector fits all standard urine leg bags
  • Available in Small (20mm), Medium (25mm), Large (30mm), and XL (35mm)
Sterile Paediatric Urine Collector Bag 100ml

Paediatric Urine Bag

Pediatric urine collector pouch tailored for effortless urine sample collection from infants and neonates.

  • 100ml volume capacity with precise 10ml scale markings
  • Hypoallergenic adhesive foam layer ensures firm contact without skin irritation
  • Suitable for both male and female infant anatomy
  • Sterile individual blister peel-pack packaging
Manufacturing Standards

Technical Specification Matrix & Global Compliance

Every urology product manufactured at Angiplast undergoes rigorous physical, chemical, and biological testing in our accredited laboratory to ensure leak-proof seals, biocompatibility, and batch-to-batch sterility.

Device Family Material Composition Available Sizes / Range Sterilisation Method Regulatory Compliance
Foley Balloon Catheter Silicone Coated Latex / 100% Pure Silicone Fr 06 to Fr 24 (2-Way / 3-Way) Ethylene Oxide (ETO) ISO 13485, CE Marked, ISO 10993 Biocompatible
Urometer System Medical-Grade Rigid ABS & Flexible PVC 500ml Chamber + 2000ml Bag Ethylene Oxide (ETO) ISO 13485, CE Marked, Pyrogen-Free
Urine Collection Bags Non-Toxic PVC Sheet (Clear/Translucent) 500ml, 750ml, 2000ml Ethylene Oxide (ETO) ISO 13485, CE Marked, EN ISO 8669-2
TUR Irrigation Set Medical Grade Non-DEHP / PVC Dual-Spike Y-Tubing (Bore 7.0mm) Ethylene Oxide (ETO) ISO 13485, CE Marked
Nelaton Catheter Kink-Resistant Thermo-Softening PVC Fr 06 to Fr 20 (Male / Female) Ethylene Oxide (ETO) ISO 13485, CE Marked
OEM & Private Label Services

Custom Contract Manufacturing for Global Medical Brands

In addition to our proprietary Angel Touch brand, Angiplast acts as an integrated CDMO/OEM contract manufacturing partner for global pharmaceutical corporations, hospital distributors, and brand owners.

  • Custom mold design and high-precision injection moulding in Class 10,000 cleanrooms
  • Private label blister packaging, customized tube lengths, and specialized connector fittings
  • Complete Technical File (STED), ISO 13485 audit trail, and Free Sale Certificates (FSC) support
  • In-house ETO sterilisation validation and lot-level laboratory bioburden testing
Cleanroom OEM manufacturing of urology disposables at Angiplast India
Export FAQ

Frequently Asked Questions by International Buyers

Essential commercial and regulatory insights for hospital procurement officers, medical device importers, and distributors.

Angiplast operates under an ISO 13485:2016 certified Quality Management System. Our urology disposables carry European CE marking, ISO 10993 biocompatibility test reports, and non-pyrogenic validation certifications to support seamless importer registration.

MOQs depend on the product SKU and custom packaging requirements. Standard production lots typically start at 5,000 units for Urometers and 10,000 units for Foley catheters or urine collection bags with customized private-label pouches.

Products are individually sealed in medical-grade paper-poly sterile blister pouches, sterilised using Ethylene Oxide (ETO) gas with validated 5-year shelf-life stability, and packed into heavy-duty 5-ply export corrugated master cartons.

Yes. Our regulatory affairs team provides complete Technical Dossiers, Device Master Files (DMF), Biocompatibility Reports, Sterilisation Validation Summaries, and notarized Free Sale Certificates (FSC) issued by Indian FDA authorities.

Request Technical Specifications & B2B Export Quotes

Connect with our technical sales engineers to discuss custom OEM configurations, tender requirements, or request sterile product samples.

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