We export to:

• The United States, European Union, Asia, the Middle East, South America, and more

We provide complete export documentation, including:

• Certificate of Origin (CO)

• Certificate of Analysis (COA)

• Certificate of Conformance (COC)

• Other documents available upon request based on international customer requirements

MOQ: Typically 5,000–10,000 pieces per item. For specific product types, we can accommodate volumes ranging from 500 pcs to 1 million pcs per month, depending on customer needs.

Lead Time: After mold completion, mass production usually takes 2–4 weeks. The exact schedule will be discussed based on your project timeline.

We offer:

• ISO Class 8 (100,000-level) cleanroom assembly services

• Coordination of EO or Gamma sterilization through qualified partners

• Referrals to QMS-certified contract manufacturers and regulatory consultants to support a one-stop verification and production process

⚠️ Please note: We do not perform sterilization or cleaning in-house, but we can help coordinate trusted third-party resources.

Yes, we can provide the following services for ODM clients:

• Logo printing

• Custom label design

• Medical-grade packaging materials (e.g., blister trays, EO sterile pack Tyvek or paper made, paper boxes)

If you require infusion-related components but wish to avoid high tooling costs, we offer access to our existing mold library for selected standard parts.
This allows you to proceed with sampling and testing without starting from scratch.

Yes. Our products can be developed in compliance with international medical standards such as FDA 21 CFR, ISO 10993, and ISO 80369 based on customer requirements.
We can also provide functionality test reports to support regulatory submissions (additional fees apply).

Mold development typically takes around 30 working days, depending on the complexity of the design.
We also support validation processes including T1 (first shot), IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) to ensure product quality and consistency during mass production.

Yes, we have experience in new product development and support small-batch trial production and test molding.
From sample development and mold design to mass production, we use a scientific and structured process to help customers verify product feasibility and accelerate market entry.

Yes. We are certified with the ISO 13485 medical device quality management system.
Products can be developed in compliance with CE MDR and FDA 510(k) requirements based on customer needs.
We also assist in validating biocompatibility and sterilization compatibility.

We provide:

• Medical-grade plastic injection molding, including mold design and fabrication

• Custom product development and assembly

• Contract manufacturing for infusion systems, needle-free connectors, CT high-pressure connectors, and related components

• OEM, ODM, and one-stop development consulting services

? We operate under an ISO 13485 quality management system, covering Class I, Class II, and Class III medical devices.