Facility

BMC MEDICAL CO., LTD.

1 recall(s) on record — most severe on record: Class I.

FDA Establishment Identifier (FEI)	3008566132
Establishment type	Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device
Location	Room 10, 17F, Building 4, Huiya Plaza, No.16 Lize Road Fengtai District Beijing, CN 10007
Registration status	Active · expires 2026
Parent company	BMC Medical Co., Ltd (owner-operator 10040296)
Brand names	Siesta Contour Nasal Mask; Siesta full face mask; Siesta nasal mask; Siesta 2 Full Face Mask, Siesta 2 Nasal Mask; Rio II Full Face Mask, Rio II Nasal Mask

Devices registered here (1)

Ventilator, Non-Continuous (Respirator)
Product code BZD (opens in a new tab) · Class II · Anesthesiology · 21 CFR 868.5905

Recalls & enforcement

Class IOngoing2026-07-15
Retroactive reporting for 2024 rework conducted at the 3B/React Health warehouse

FDA warning letters (1)

Warning Letter2026-05-21
Warning Letter (opens in a new tab) · Beijing

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-09-07. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-09-07. Verify this facility record at FDA → (opens in a new tab)

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