FDA Registration
Active
🇹🇼 Taiwan
HEADSTAR MEDICAL PRODUCTS CO., LTD
Reg #: 9616354
·
FEI: 3003418980
·
Expires 2026
Products
25
Proprietary Names
19
Establishment Types
2
Classifications
25
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Registration Details
- Registration Name
- HEADSTAR MEDICAL PRODUCTS CO., LTD
- Registration Number
- 9616354
- FEI Number
- 3003418980
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 7F, No. 14, WU-GONG 5th Rd., WU-GU Dist.
- City
- NEW TAIPEI CITY
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K121770
Owner / Operator
- Firm Name
- HEADSTAR MEDICAL PRODUCTS CO., LTD
- Operator Number
- 9039454
- Address
- 9F No. 288, Sec. 2, New Taipei Blvd.,, Xinzhuang Dist.,
- City
- NEW TAIPEI CITY
- State
- TW-NOTA
- Postal Code
- 242
- Country
- TW
- Correspondent
- Shu - Cheng
US Agent
- Business Name
- Jeco, Inc.
- Contact Name
- Tim Juang
- Address
- 623 S Doubleday Avenue
- City
- Ontario
- State
- CA
- ZIP
- 91761
- Country
- US
- [email protected]
- Phone
- 909 5631600
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2000-07-24 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2011-02-25 |
| Humidifier, Non-Direct Patient Interface (Home-Use) | KFZ | Class 1 | Anesthesiology | No | 2010-01-21 |
| Mouthpiece, Breathing | BYP | Class 1 | Anesthesiology | No | 2011-02-25 |
| Gag, Mouth | KBN | Class 1 | Ear, Nose, Throat | No | 2000-07-24 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | Class 1 | Anesthesiology | No | 2010-03-15 |
| Bag, Reservoir | BTC | Class 1 | Anesthesiology | No | 2011-11-29 |
| Catheters, Suction, Tracheobronchial | BSY | Class 1 | Anesthesiology | No | 2006-07-20 |
| Regulator, Pressure, Gas Cylinder | CAN | Class 1 | Anesthesiology | No | 2012-05-17 |
| Airway, Nasopharyngeal | BTQ | Class 1 | Anesthesiology | No | 2011-02-25 |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | Class 1 | Anesthesiology | No | 2000-07-24 |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | NOC | Class 1 | General, Plastic Surgery | No | 2005-06-24 |
| Drain, Tee (Water Trap) | BYH | Class 1 | Anesthesiology | No | 2010-03-15 |
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 2013-10-30 |
| Ventilator, Emergency, Manual (Resuscitator) | BTM | Class 2 | Anesthesiology | No | 2007-11-07 |
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 2000-07-24 |
| Mask, Oxygen, Low Concentration, Venturi | BYF | Class 1 | Anesthesiology | No | 2010-03-17 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2007-11-07 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2000-07-24 |
| Connector, Airway (Extension) | BZA | Class 1 | Anesthesiology | No | 2010-03-15 |
| Mask, Oxygen, Non-Rebreathing | KGB | Class 1 | Anesthesiology | No | 2011-02-25 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | Class 1 | Anesthesiology | No | 2010-03-15 |
| Valve, Non-Rebreathing | CBP | Class 2 | Anesthesiology | No | 2011-03-29 |
| Halter, Head, Traction | HSS | Class 1 | Orthopedic | No | 2011-02-25 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2000-07-24 |
Proprietary Names
Headstar
HEADSTAR
HEADSTAR MOUTH GRAG
HP-1102
AMBU HAND POWER SUCTION PUMP
HP-1108
HEADSTAR OXYGEN TUBING
FINGER GUARD
Headstar Medical
Evelyn Chen
HEADSTAR AIRWAY
HP SERIES
Headstar Venturi Mask
HEADSTAR SUCTION BULB
Headstar Swivel Connector
Bawmed
HEADTAR OXYGEN NASAL CANNULA
HP-1105
HP-1103
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)