FDA Registration
Active
🇨🇳 China
GFA Production Xiamen Co., Ltd.
Reg #: 3008384335
·
FEI: 3008384335
·
Expires 2026
Products
30
Proprietary Names
1
Establishment Types
2
Classifications
30
Registration Details
- Registration Name
- GFA Production Xiamen Co., Ltd.
- Registration Number
- 3008384335
- FEI Number
- 3008384335
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- #20 HuLi Industrial Park, Mei Xi Dao
- City
- Tong An, Xiamen Fujian
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K171961
Owner / Operator
- Firm Name
- GFA Production Xiamen Co., Ltd.
- Operator Number
- 9073017
- Address
- No. 20 Huli Industrial Park, Mei Xi Dao, Tong'an District
- City
- Xiamen
- State
- Fujian
- Postal Code
- 361100
- Country
- CN
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mask, Oxygen, Non-Rebreathing | KGB | Class 1 | Anesthesiology | No | 2024-01-10 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2015-01-08 |
| Brush, Scrub, Operating-Room | GEC | Class 1 | General, Plastic Surgery | No | 2015-01-08 |
| Pad, Eye | HMP | Class 1 | General, Plastic Surgery | No | 2025-09-29 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2010-05-09 |
| Depressor, Tongue, Non-Surgical | FMA | Class 1 | General Hospital | No | 2026-03-23 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2026-03-23 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2010-05-09 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2010-05-06 |
| First Aid Kit With Drug | LRR | Class N | Unknown | No | 2011-04-13 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2012-03-07 |
| Valve, Non-Rebreathing | CBP | Class 2 | Anesthesiology | No | 2020-06-03 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2026-03-23 |
| Vinyl Patient Examination Glove | LYZ | Class 1 | General Hospital | No | 2013-07-10 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2020-06-03 |
| First Aid Kit Without Drug | OHO | Class 1 | General, Plastic Surgery | No | 2016-12-28 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2025-09-29 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2010-05-23 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2010-05-06 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2024-08-21 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2010-05-06 |
| Thermometer, Clinical Color Change | FQZ | Class 1 | General Hospital | No | 2010-05-06 |
| Finger Cot | LZB | Class 1 | General Hospital | No | 2016-04-05 |
| Scissors, Medical, Disposable | JOK | Class 1 | General Hospital | No | 2010-05-06 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2014-02-18 |
| Stapler, Skin | QQS | Class 1 | General Hospital | No | 2022-04-22 |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | NOC | Class 1 | General, Plastic Surgery | No | 2010-05-06 |
| Bandage, Cast | ITG | Class 1 | Physical Medicine | No | 2010-05-09 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2025-12-02 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2010-05-06 |
Proprietary Names
Disposable Face Mask
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device