What CE FCC RoHS KC PSE EAC MDL and ISO 13485 each cover, and which ones you will be asked for.
Product Certifications On The Irrigator Series
ABrite Tech's self-developed oral irrigator and water flosser series carries CE, FCC, RoHS, MDL, KC, PSE and EAC. Those are product-level marks tied to destination markets: CE for Europe, FCC for the United States, KC for Korea, PSE for Japan and EAC for the Eurasian Economic Union.
System Certifications Behind The Line
ISO 9001 covers general quality management. ISO 13485 covers quality management for medical devices. MDSAP is the single-audit programme recognised by several regulators. A buyer asking whether your supplier is auditable is asking about these three.
What Our ISO 13485 Certificate Actually Says
Certificate 381250289R0S, issued by Shanghai POSI Certification against GB/T 42061-2022 / ISO 13485:2016, valid to 15 September 2028. The registered scope is manufacture and distribution of disinfect boxes, electric oral irrigators, teeth whitening LED lights, dental trays and mouth openers, for export.
FDA Registration Is Not FDA Approval
ABrite Tech holds FDA registration qualification. Registration means the establishment is listed with the agency. It is not the same as clearance or approval of a specific device, and your listing copy should not imply otherwise.
Which Files To Request Before You Order
Ask for the certificate covering your destination market, the system certificates, and the test report behind any figure you intend to print - water pressure, pulse frequency or IPX rating. We send them on request with your sample.
