MedTech & Medical Devices
CE and FDA-cleared devices from audited OEM partners
Class I and Class II medical devices, diagnostic equipment, and consumables from CE-marked and FDA-registered Chinese OEM manufacturers. Full technical files, IFU, and post-market surveillance documentation available.
Device Categories
Diagnostic devices, monitoring equipment, surgical consumables, rehabilitation aids, and point-of-care testing kits from audited OEM partners.
Regulatory Documentation
CE technical files, FDA 510(k) summaries, IFU translations, and post-market surveillance plans available for all listed devices.
OEM & Private Label
Private label and OEM customisation available for select device categories. Minimum order quantities and lead times vary by device.
At a Glance
Classification
Class I & II
Clearances
CE · FDA 510(k)
Lead Time
8–16 weeks
MOQ
By device type
Request a Device Profile
Describe the device category, intended use, and target market. We will match you with verified OEM partners and provide regulatory documentation.