Frequently asked questions
Straight answers for OEM/ODM buyers: order quantities, lead times, customization, and exactly what our certifications do and do not cover.
Is there a minimum order quantity (MOQ)?
There is no MOQ floor on customization. Below the free-tier quantity, silkscreen printing or laser engraving is available for a per-order fee, so even a small trial order can carry your brand. Customization becomes free of charge from 500 units (laser engraving) or 1,000 units (silkscreen printing and custom colour boxes). Order quantities and unit pricing are quoted per model in your RFQ reply.
How long is the production lead time?
Base production lead time is about one month. Customization adds its own lead time on top: roughly two weeks for laser engraving or a custom colour box, and two weeks to one month for silkscreen printing, excluding production.
Can you manufacture under our brand (OEM / private label)?
Yes — that is the core business. Your logo can be applied by silkscreen printing or laser engraving on any platform, and the consumer line supports fully custom colour boxes. Laser engraving is the fastest route: the laser is in-house, and samples take 1–2 days from an AI artwork file.
What is the difference between the medical line and the consumer line?
The hardware is identical. DQ22, DQ30 and DQ58 are additionally offered as registered medical builds under NMPA Class II certificate 粤械注准 20262090588, manufactured in the group's ISO 13485 facility under a Class II production licence — for pharmacy chains, medical distributors and channels that require a registered device. Consumer builds are produced in SiLeap's own dedicated workshop.
Which models are NMPA-registered medical devices?
Three: DQ22, DQ30 and DQ58, covered by NMPA Class II registration 粤械注准 20262090588. The registration is public — you can verify it yourself on the NMPA database.
Which certifications cover US e-commerce?
Every SiLeap aspirator carries a CPC (Children's Product Certificate) held in SiLeap's own name — a mandatory upload for children's products on Amazon, Temu and Walmart US — alongside FCC. The three medical-line models are additionally FDA-registered as 510(k)-exempt devices.
Can the registered medical builds be customized?
Within the limits of the registration. The NMPA registration freezes the colour-box dimensions, the IFU (customer information may only be added), the outer-carton dimensions and the primary product materials. Product colour, accessories and box artwork can change, provided the medically required content is retained.
How fast do you respond to an RFQ?
Within 1–2 business days, with model recommendations, certification paths and packaging options matched to your target market and volumes.
Where are the products manufactured?
In Panyu District, Guangzhou, China. The consumer line runs in SiLeap's own dedicated aspirator workshop; the registered medical line is manufactured in the AIMEI group's ISO 13485 certified, Class II licensed facility.
Who actually holds your certificates?
Two group entities, and every certificate on this site names its holder. Guangzhou SiLeap Medical Technology holds the CPC, FCC and the silicone-tip cytotoxicity report. ISO 13485, the Class II production licence, the FDA registration and the NMPA registration itself are held by Guangzhou Aimei Intelligent Technology — the group facility that manufactures the medical line. The certifications page lists the full scope per certificate.
A question we didn't answer?
Send it with your RFQ — engineering answers in 1–2 business days.
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