Custom Curved HDPE Medical Mounting Card for Interventional Catheter Kits

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This custom curved HDPE medical mounting card is purpose-built for interventional catheter manufacturers who need secure, sterile, cost-effective device fixation inside their packaging. The curved profile matches the natural shape of interventional catheters and guidewires, preventing device movement during sterilization, storage and international shipping — eliminating the scratching, kinking and damage that happens with flat generic mounting cards.

Product Overview

Our curved HDPE medical mounting card is a die-cut rigid card used as the internal fixation component for interventional catheter kits, angiography catheter sets, electrophysiology catheters and other long, flexible sterile medical devices. The card holds the coiled or looped catheter securely in place inside a sterilization pouch or rigid medical blister tray, preventing the device from shifting, tangling or being damaged during handling and transport.

Manufactured from medical grade high-density polyethylene (HDPE), the mounting card offers excellent rigidity, chemical resistance and sterilization compatibility. The custom curved shape is designed specifically for your catheter dimensions and coil diameter, ensuring a perfect fit every time. All production is performed in our ISO 7 (Class 10000) cleanroom under ISO 13485 quality management system, with full material traceability and biocompatibility documentation available for every batch.

Key Design Advantages

Custom Curved Profile for Catheters

The curved shape is custom-designed to match your catheter’s natural coil diameter and loop profile, holding the device securely without kinking or stressing the catheter tubing. Unlike flat cards that force catheters into unnatural shapes, our curved design reduces device damage rates by over 80% during shipping.

Medical Grade HDPE Material

Made from medical grade HDPE with full biocompatibility certification (ISO 10993), excellent chemical resistance, and consistent rigidity. HDPE is the industry standard material for medical mounting cards because it does not leach harmful substances, withstands EO and gamma sterilization, and provides the right balance of stiffness and flexibility for secure device retention.

Precision Die-Cut with Smooth Edges

All mounting cards are die-cut with precision steel rule dies, producing clean, burr-free edges that will not puncture sterile pouches or tear packaging materials. We can include custom snap features, retention slots, cutouts and printing to match your exact packaging design. Tight dimensional tolerances of ±0.2mm ensure consistent fit across every production batch.

Cleanroom Manufactured & Fully Traceable

All production takes place in our ISO 7 (Class 10000) cleanroom under ISO 13485 quality management system. Every batch comes with full material certificates, biocompatibility reports, dimensional inspection records and complete traceability from raw resin lot to finished product. We support your sterile barrier system validation with all required documentation and test reports.

Material & Sterilization Compatibility

This curved HDPE medical mounting card is compatible with the most common medical device sterilization methods, making it suitable for a wide range of interventional catheter and sterile device packaging applications:

  • EO (Ethylene Oxide) Sterilization: HDPE withstands standard EO sterilization cycles with no material degradation, discoloration or dimensional change
  • Gamma Irradiation: Compatible with standard gamma sterilization doses (25-50 kGy) with minimal material change
  • E-beam Sterilization: Suitable for electron beam sterilization processes
  • Not recommended for steam autoclave: HDPE has a melting point of ~130°C and is not suitable for high-temperature steam sterilization

The mounting card works as part of a complete sterile barrier system when paired with Tyvek lids, medical grade paper, or sterilization pouches. We can provide complete packaging system solutions including the mounting card, blister tray, lid material and outer pouch for your full device package.

Technical Specifications

Material Medical Grade HDPE (High-Density Polyethylene), natural or white
Shape Custom curved profile (this product: curved for interventional catheters) — fully customizable to your device shape
Thickness 0.5mm – 2.0mm (standard: 0.8mm / 1.0mm)
Overall Dimensions Fully customizable (standard range: 50mm × 100mm to 300mm × 400mm)
Dimensional Tolerance ±0.2mm (cut dimensions), ±0.1mm (critical features)
Custom Features Snap retention slots, cutouts, holes, bend lines, printing, barcodes, lot coding
Sterilization Compatibility EO, Gamma Irradiation, E-beam (not for steam autoclave)
Manufacturing Environment ISO 7 (Class 10000) Cleanroom, ISO 13485 certified
Certifications & Documentation ISO 10993 Biocompatibility, COA, full material traceability, FAI reports, validation support
MOQ 5,000 pieces (custom shapes); prototype runs available for testing

Typical Applications

This curved HDPE medical mounting card is suitable for a wide range of sterile medical device fixation applications, including:

  • Interventional catheter kits (coronary, peripheral, neurovascular)
  • Angiography catheter and guidewire sets
  • Electrophysiology catheters and ablation devices
  • Central venous catheter kits and PICC lines
  • Urinary catheters and drainage catheter sets
  • Long flexible medical devices that require coiled or looped packaging
  • Any sterile medical device that needs secure fixation inside a pouch or blister package

Our Custom Design & Manufacturing Capability

This curved mounting card is just one example of our custom medical mounting card capability. We can design and manufacture mounting cards in any shape, size, thickness and material to match your exact device and packaging requirements. Our process includes:

  1. Free design review: We analyze your device dimensions, weight, sterilization method and packaging requirements at no cost, and recommend the optimal mounting card design and material.
  2. Custom die design & prototyping: We design custom steel rule dies and produce prototype samples within 5-7 days for fit testing with your actual devices.
  3. Precision die-cut manufacturing: High-volume production with tight dimensional tolerances, 100% visual inspection, and cleanroom packaging.
  4. Value-added services: Custom printing, barcoding, lot coding, bending, assembly with other packaging components, and complete kitting services.
  5. Full validation support: We provide all required documentation and support for your sterile barrier system validation, including installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) support.

We also provide complete sterile packaging system solutions, including matching medical blister trays, Tyvek lids, sterilization pouches and mounting cards for your full device package.

Frequently Asked Questions

Q: Can you manufacture a custom curved mounting card for my specific catheter size?

A: Yes, 100%. This product is an example of a curved mounting card we designed for a specific interventional catheter size, but we can design and manufacture custom mounting cards in any shape, curve radius, size and thickness to match your exact catheter or device dimensions. Just send us your device drawings or actual samples, and we’ll provide a free design review and custom quotation within 2 business days.

Q: What is the minimum order quantity for custom mounting cards?

A: For custom-shaped mounting cards, the standard MOQ is 5,000 pieces after die completion. We also offer smaller prototype runs of 50-200 pieces for fit testing and validation before mass production. The die cost is a one-time fee, and we offer die cost rebates for high-volume annual orders.

Q: Do you provide biocompatibility and validation documentation?

A: Yes. All our medical grade HDPE material comes with full ISO 10993 biocompatibility test reports, material certificates of analysis (COA), and complete resin lot traceability. We provide first article inspection (FAI) reports, dimensional inspection records, cleanroom environmental monitoring data, and all required documentation to support your sterile barrier system validation and regulatory submissions. We can also support IQ/OQ/PQ validation activities for your packaging process.

Q: How long does the custom design and production process take?

A: Typical timeline: 2-3 days for design review and quotation, 5-7 days for die design and prototype sample delivery, 10-15 days for production die manufacturing and first article validation, and 7-10 days for mass production. Total lead time from design approval to mass production delivery is approximately 3-4 weeks. Rush timelines can be accommodated for urgent projects.

Need a Custom Curved HDPE Medical Mounting Card for Your Catheter Kit?

Send us your catheter dimensions or device samples today, and our engineering team will provide a free custom design review, material recommendation and detailed quotation within 2 business days. As an ISO 13485 certified manufacturer with ISO 7 cleanroom production, we’ve supplied custom medical mounting cards and sterile packaging solutions to medical device manufacturers in over 30 countries.

Request Free Custom Design Quote →

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