FDA I II类医疗器械 510k（豁免）注册申请表
Not sure which tests to do?
Tell us your product and target market, and a technical consultant will select the minimum necessary test combination — plan and quotation within 1 business day.
FDA I II类医疗器械 510k（豁免）注册申请表
Tell us your product and target market, and a technical consultant will select the minimum necessary test combination — plan and quotation within 1 business day.
4 required fields, done in 30 seconds; email optional. The consultant will provide test items, standards and a quotation based on your product and target market.
A technical consultant will contact you within 1 business day.
Call 0755-86642861 DirectlySelect the test items to evaluate, or choose your industry. After submission an engineer will issue a formal quotation based on samples, standards and lead time. No prices are published online.
Whole-product certification programmes (EMC + safety + radio + global market access) are quoted as a package; engineers break the test items down by model before issuing a formal quotation.
Testing cost depends on sample quantity, applicable standards, test duration and non-standard items. No prices are published online. Once this configuration is submitted, an engineer will assess it and issue a formal quotation covering test execution and accredited reporting.
Every report has a unique number and a verification channel. After receiving a report, we recommend verifying it yourself using the three steps below.
Two engineers are assigned by product line. After scanning, just state your product and items to test for an initial verbal assessment.
