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We run every batch through three separate HPLC tests before anything gets a COA, and we hold a retest period of 18 months from the manufacture date if you ever need verification—it's pretty standdard but we guarantee it.
The ethylene oxide sterilization cycle is validated per ISO 11135, and each unit comes with a sterility indicator, so you can see it's been through the process; we also include a gamma-irradiated option on request if your facility prefers that. 37 separate quality checkpoints across assembly, packging, and labeling. We keep a reference sample from every lot in our archive for the duration of retest window—usually 5 years after you receive it—so if something comes up down the line, our company can pull that lot and re-run a full panel.
You'll get a batch-specific COA with each shipment, and the testing covers things like balloon burst pressure, catheter tensile strength, and connector leak rate at both the 18Fr size and at the color-coding dye level, believe it or not. And we've had exactly zero complaints about misprinted or mismatched color bands in the last two years of production.
ISO 13485 and CE and FDA certification are all current, but also LGA and FSC if you're shiping into markets that require those specifically—we don't always lead with those. The silicon material itself is USP Class VI tested for cytotoxicity, sensitization, and irritation, which isn't something every silicone catheter supplier does, so that's worth knowing if your compliance team asks for it.
MOQ is 5000 pieces and lead time is 15-20 working days, but we can sometimes split the order into two shipments if you need 2500 first. We will not cancel a lot that fails its own retest—we replace it at no cost and cover the freight back.
Our MOQ is 5000 pieces. We don't typically break that for first orders, but we can discuss sample options if you need to evaluate the product before committing to a full batch.
Yes, we can provide copies of all our certifications—CE, ISO 13485, FDA, LGA, and FSC—upon request. Just let us know what you need, and we'll send them over.
Each size has a distinct color band near the hub for quick ID. For the 18Fr, it's a specific color that's easy to spot, so you won't mix it up with other sizes in your kit.
Each catheter is EO sterilized and individually packaged to maintain sterility until use. The carton contains 320 pieces, packed in a way that protects the product during shipping—usually in smaller inner boxes or trays.
Standard lead time is 15-20 working days after order confirmation. For urgent orders, we can sometimes expedite to around 10-12 days depending on current production load—just check with us before placing.
