We’ve run these through our own QC lab with a force gauge, and the <5N on the 36/37U models is consistent—actually a bit smoother than some other disposable pens we’ve tested, though the 74/80U models do require a firmer press at <8N, which is still within spec for most users but worth noting if your patients have limited hand strength.
MOQ typically runs 1,000 units for standard configurations, but we can flex down to 500 if you’re doing a pilot run or a small clinical batch—just confirm lead time because custom scale lines or color changes add about 20 days or so to the production schedule. Payment terms are usually 30% deposit with the balance before shipment, and we accept T/T or L/C at sight, though we’ve also done net 30 for repeat buyers with a solid purchasing history.
Documentation includes a full COA form our HPLC analysis, a TDS, and the CE declaration of conformity—the FDA 510K is still pending, but the CDE registration is active and FTO clearance is in place, so you’re covered for most non-US markets. We also provide a batch-specific SDS if your compliance team needs it, but that’s typically a separate request.
Teh 3mL cartridge capacty is pretty standdard for semaglutide or tirzepatide, but it’s not ideal for high-dose insulin formulations that require larger volumes—those usually need a different pen body anyway. Shipping is via DHL or FedEx for small orders, or sea freight for pallet quantities, and we usually have stock for the 36U and 50U models, but the 74U and 80U can sometimes run a 2-3 week backorder if demand spikes.
One thing buyers don’t always ask about is pressing force variance between units—we’ve seen a 0.5N difference across a batch, which is within tolerance but can feel inconsistent if you’re doing a multi-pen study. It’s not a dealbreaker, but it’s worth checking your own sample before committing to a large order.
Our MOQ for the HL100S-D Series is typically 1,000 units per model, but we can discuss smaller trial orders if you're just getting started.
The FDA 510K is currently pending, but we hold CE certification and CDE registration. We expect the FDA clearance to finalize within the next quarter.
Yes, we offer customization of the scale lines, dosage increments, and even the pen color to match your medication and branding needs.
For an order of 10,000 units, lead time is usually around 4 to 6 weeks from confirmation, depending on customization complexity and current production load.
Each pen is individually blister-packed in a sterile pouch, then shipped in bulk cartons. They're designed for room temperature storage, away from direct sunlight.