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FDA 510(k)

Biomic Color Opaque

K-Number: K250534 · 2025-05-20

ApplicantAidite (Qinhuangdao) Technology Co., Ltd.
Decision Date2025-05-20
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Biomic Color Opaque is the device name listed in this FDA 510(k) record. The listed applicant is Aidite (Qinhuangdao) Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-05-20 under 510(k) 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. The listed applicant is Aidite (Qinhuangdao) Technology Co., Ltd.. The 510(k) number is K250534.

When did Biomic Color Opaque receive FDA 510(k) clearance?

Biomic Color Opaque received FDA 510(k) clearance on 2025-05-20, under 510(k) number K250534.

Who is the listed applicant for Biomic Color Opaque?

The FDA 510(k) record lists Aidite (Qinhuangdao) Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Biomic Color Opaque?

The FDA product code for Biomic Color Opaque is EIH.

Other records listing Aidite (Qinhuangdao) Technology Co., Ltd. as applicant

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Related Devices (Code: EIH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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