Facility

GaleMed (Xiamen) Co., Ltd.

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

Key facts

1recalls · worst Class I

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3006783791
Establishment type	Manufacture Medical Device
Location	Xiamen Area of China (Fujian) Pilot Free Trade Zone, 39, Section 3, Haijing East Road XIAMEN Fujian, CN 36102
Registration status	Active · expires 2026
Parent company	GaleMed Corporation (owner-operator 8043316)
Brand names	Disposable Adjustable PEEP Valve MR Conditional; PEEP Valve, 5-20cmH2O, 30F w/adapter

Activity by year

Recalls (1)

Devices registered here (1)

Attachment, Breathing, Positive End Expiratory Pressure
Product code BYE (opens in a new tab) · Class II · Anesthesiology · 21 CFR 868.5965

Recalls & enforcement

Class ITerminated2019-05-30
Reports of pressure relief manifold venting gas below the standard pressure.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “GaleMed (Xiamen) Co., Ltd. (FEI 3006783791) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3006783791-galemed-xiamen-co-ltd/

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