Biomic Color Opaque
K-Number: K250534 · 2025-05-20
Decision Date2025-05-20
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Biomic Color Opaque is a medical device manufactured by Aidite (Qinhuangdao) Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-05-20 under approval number K250534. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Biomic Color Opaque?
Biomic Color Opaque is a medical device that received FDA 510(k) clearance on 2025-05-20. It is manufactured by Aidite (Qinhuangdao) Technology Co., Ltd.. The 510(k) number is K250534.
When was Biomic Color Opaque approved by the FDA?
Biomic Color Opaque received FDA 510(k) clearance on 2025-05-20, under approval number K250534.
What company makes Biomic Color Opaque?
Biomic Color Opaque is manufactured by Aidite (Qinhuangdao) Technology Co., Ltd..
What is the FDA product code for Biomic Color Opaque?
The FDA product code for Biomic Color Opaque is EIH.
Other Devices by Aidite (Qinhuangdao) Technology Co., Ltd.
Related Devices (Code: EIH)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.