Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616354

FEI Number

3003418980

Entity Name

HEADSTAR MEDICAL PRODUCTS CO., LTD

City/State/Country

NEW TAIPEI CITY, TW

Establishment Address

7F, No. 14, WU-GONG 5th Rd., WU-GU Dist., NEW TAIPEI CITY 248, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

HEADSTAR MEDICAL PRODUCTS CO., LTD (Owner Number: 9039454)

Owner / Operator Contact Address

9F No. 288, Sec. 2, New Taipei Blvd.,, Xinzhuang Dist.,, NEW TAIPEI CITY, TW-NOTA 242, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Headstar HEADSTAR Headstar Headstar Headstar Headstar HEADSTAR MOUTH GRAG HP-1102 Headstar Headstar Headstar AMBU HAND POWER SUCTION PUMP Headstar Headstar Headstar HP-1108 HEADSTAR OXYGEN TUBING Headstar FINGER GUARD Headstar Headstar Medical Evelyn Chen Headstar Headstar HEADSTAR AIRWAY HP SERIES Headstar Venturi Mask Headstar Evelyn Chen Headstar Headstar HEADSTAR SUCTION BULB Headstar Swivel Connector Headstar Headstar Headstar

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2000-07-24
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2011-02-25
KFZ	Humidifier, Non-Direct Patient Interface (Home-Use)	Anesthesiology	Class 1	868.5460	2010-01-21
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2011-02-25
KBN	Gag, Mouth	Ear, Nose, Throat	Class 1	874.4420	2000-07-24
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2010-03-15
BTC	Bag, Reservoir	Anesthesiology	Class 1	868.5320	2011-11-29
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2006-07-20
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	Class 1	868.2700	2012-05-17
BTQ	Airway, Nasopharyngeal	Anesthesiology	Class 1	868.5100	2011-02-25
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2000-07-24
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2005-06-24
BYH	Drain, Tee (Water Trap)	Anesthesiology	Class 1	868.5995	2010-03-15
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2013-10-30
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2007-11-07
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2000-07-24
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	2010-03-17
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2007-11-07
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2000-07-24
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2010-03-15
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2011-02-25
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2010-03-15

Official Correspondent

Shu Cheng

US Agent Details

Tim Juang Business: Jeco, Inc. Email: tim@jeco-inc.com Phone: (909) 5631600

Related Public Records

Same Entity

HEADSTAR MEDICAL PRODUCTS CO., LTD

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K163485	Adherium (Nz), Ltd.	SmartTouch	2017-08-30
K781467	Travenol Laboratories, S.A.	U-FLOAT VALVE 2D9023	1978-09-07
K883982	Iberhospitex, S.A.	DRENOVAC	1989-02-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0037-2010	Airgas Puritan Medical Puritan Medical Unit	1	AGI-2237 Portable 2 Cylinder Manifold Cart, for connecting medical gas cylinders.
Z-0038-2010	Airgas Puritan Medical Puritan Medical Unit	1	AGI-2238 Portable 4 Cylinder Manifold Cart, for connecting medical gas cylinders.
Z-0031-2026	Percussionaire Corporation	1	Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use
Z-0039-2010	Unomedical	2	Infant Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID # 5801, 12-8713, 732-E, and 2206. Packaged under the name of Dynarex, Evergreen, Mada and Hospitak. Recalled codes may be identified by examining the patient valve housing immediately below the right-angle exhalation port, where the retention ring should be visible. MPR units with a clear or transparent ring, as well as those where no ring can be seen, should be returned. MPR units with a blue retention ring are not affected and do not need to be returned.
Z-0040-2010	Unomedical	2	Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID #s: 5804; 12-8709, 727-E; 727MM, 2203. Packaged under the name of Dynarex, Evergreen, Mada and Hospitak.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616354. Last updated year: 2026. Please use registration number 9616354 when referencing this establishment in official correspondence.