Facility

GALEMED CORP.

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

Key facts

1recalls · worst Class I

2inspections · worst OAI

—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)	3003319165
Establishment type	Manufacture Medical Device
Location	No.87, LI-GONG 2ND RD., WU-JIA Yilan, TW 268
Registration status	Active · expires 2026
Parent company	GaleMed Corporation (owner-operator 8043316)
Brand names	BabI PIus N Bag; BABI PLUS NEONATAL RESUSCITATION BAG; nBag Resuscitator

Activity by year

Recalls (1)
Inspections (2)

Devices registered here (1)

Ventilator, Emergency, Manual (Resuscitator)
Product code BTM (opens in a new tab) · Class II · Anesthesiology · 21 CFR 868.5915

Recalls & enforcement

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

FDA inspections (2)

OAI2024-08-08
Official Action Indicated · Compliance: Devices
VAI2018-12-06
Voluntary Action Indicated · Compliance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

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 CORP. (FEI 3003319165) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003319165-galemed-corp/

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