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My DashboardInspection TrackerWarning LettersBMC Medical Co., Ltd.

All Warning Letters

BMC Medical Co., Ltd.

Warning LetterOpen

BMC Medical Co., Ltd., No. 16 Lize Road Room 10, 17F Building 4, Huiya Plaza Fengtai Qu Beijing Shi , 100073 China, (b)(6)Issued May 20, 2026Center for Devices and Radiological Health

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations3

Issue DateMay 20, 2026

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: BMC Medical Co., Ltd.
Location: BMC Medical Co., Ltd., No. 16 Lize Road Room 10, 17F Building 4, Huiya Plaza Fengtai Qu Beijing Shi , 100073 China, (b)(6)
FEI Number: N/A
Country: China
Issue Date: May 20, 2026
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Subject

CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded

BMC Medical Co., Ltd. FDA Warning Letter, May 20, 2026