FDA applicant
Anrei Medical (Hangzhou) Co., Ltd.
FDA records 6 decisions for Anrei Medical (Hangzhou) Co., Ltd. (Hangzhou, CN) from 2020 to 2022: 6 510(k) clearances. Most are in product codes GCA (Biliary Catheter For Stone Removal That May…) and EOQ (Bronchoscope (Flexible Or Rigid)). Since 2016 its 510(k)s took a median of 197 days from receipt to decision, against 167 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Anrei Medical (Hangzhou) Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2020.
Planning a device like Anrei Medical (Hangzhou) Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Anrei”
FDA records each applicant name separately; these may or may not be the same firm.