Data / Medical devices / Taiwan / Headstar Medical Products Co., Ltd

Headstar Medical Products Co., Ltd: FDA-registered device maker in New Taipei City, Taiwan, 2 510(k) clearances

Name: Headstar Medical Products Co., Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Headstar Medical Products Co., Ltd is registered with the FDA (registration 9616354) in New Taipei City, Taiwan. It lists 25 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 17, 2013. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 9616354
FEI number: 3003418980
Address: 7F, No. 14, WU-GONG 5th Rd., WU-GU Dist., New Taipei City, Taiwan, 248
Owner or operator: HEADSTAR MEDICAL PRODUCTS CO., LTD (9039454)
Roles: Contract manufacturer, Manufacturer
First device listed: July 24, 2000
Registered through: 2027
Brand names listed: AMBU HAND POWER SUCTION PUMP, Bawmed, Evelyn Chen, FINGER GUARD, HEADSTAR, HEADSTAR AIRWAY, HEADSTAR MOUTH GRAG, HEADSTAR OXYGEN TUBING and more

Devices it lists

Device	Product code	Class	Role	Source
Airway, Nasopharyngeal	BTQ	1	Manufacturer	accessdata.fda.gov
Airway, Oropharyngeal, Anesthesiology	CAE	1	Manufacturer	accessdata.fda.gov
Apparatus, Suction, Single Patient Use, Portable, Nonpowered	GCY	1	Manufacturer	accessdata.fda.gov
Bag, Reservoir	BTC	1	Manufacturer	accessdata.fda.gov
Cannula, Nasal, Oxygen	CAT	1	Manufacturer	accessdata.fda.gov
Catheters, Suction, Tracheobronchial	BSY	1	Manufacturer	accessdata.fda.gov
Circuit, Breathing (W Connector, Adaptor, Y Piece)	CAI	1	Manufacturer	accessdata.fda.gov
Connector, Airway (Extension)	BZA	1	Manufacturer	accessdata.fda.gov
Drain, Tee (Water Trap)	BYH	1	Manufacturer	accessdata.fda.gov
Gag, Mouth	KBN	1	Manufacturer	accessdata.fda.gov
Halter, Head, Traction	HSS	1	Manufacturer	accessdata.fda.gov
Humidifier, Non-Direct Patient Interface (Home-Use)	KFZ	1	Manufacturer	accessdata.fda.gov
Laryngoscope, Rigid	CCW	1	Manufacturer	accessdata.fda.gov
Mask, Oxygen	BYG	1	Manufacturer	accessdata.fda.gov
Mask, Oxygen, Low Concentration, Venturi	BYF	1	Manufacturer	accessdata.fda.gov
Mask, Oxygen, Non-Rebreathing	KGB	1	Manufacturer	accessdata.fda.gov
Mouthpiece, Breathing	BYP	1	Manufacturer	accessdata.fda.gov
Nebulizer (Direct Patient Interface)	CAF	2	Manufacturer	accessdata.fda.gov
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	CCQ	1	Manufacturer	accessdata.fda.gov
Regulator, Pressure, Gas Cylinder	CAN	1	Manufacturer	accessdata.fda.gov
Set, Tubing And Support, Ventilator (W Harness)	BZO	1	Manufacturer	accessdata.fda.gov
Splint, Extremity, Non-Inflatable, External, Non-Sterile	NOC	1	Manufacturer	accessdata.fda.gov
Splint, Hand, And Components	ILH	1	Manufacturer	accessdata.fda.gov
Valve, Non-Rebreathing	CBP	2	Contract manufacturer	accessdata.fda.gov
Ventilator, Emergency, Manual (Resuscitator)	BTM	2	Contract manufacturer, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 17, 2013	K121770	HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZER	CAF	Substantially Equivalent	Headstar Medical Products Co., Ltd.	accessdata.fda.gov
June 6, 2001	K002846	HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR	BTM	Substantially Equivalent	Headstar Medical Products Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated April 17, 2013. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.