FDA Registration
Active
🇨🇳 China
XIAMEN FIRSTCARE IMP. & EXP. CO.,LTD.
Reg #: 3015422337
·
FEI: 3015422337
·
Expires 2026
Products
29
Proprietary Names
75
Establishment Types
1
Classifications
29
Registration Details
- Registration Name
- XIAMEN FIRSTCARE IMP. & EXP. CO.,LTD.
- Registration Number
- 3015422337
- FEI Number
- 3015422337
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 602-1, Bldg. 2A, Torch Xinke Plaza, No.2 Weili Road
- City
- Xiamen Fujian
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K121526
Owner / Operator
- Firm Name
- Xiamen FirstCare Imp. & Exp. Co.,ltd.
- Operator Number
- 10062096
- Address
- 602, No.786, East Lian Qian Road, Siming District
- City
- Xiamen
- State
- Fujian
- Postal Code
- 361000
- Country
- CN
- Correspondent
- QINGHONG GU
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Pressure Applying | KNM | Class 1 | Physical Medicine | No | 2019-12-18 |
| Airway, Nasopharyngeal | BTQ | Class 1 | Anesthesiology | No | 2020-11-17 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2023-12-18 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2020-04-12 |
| Light, Examination, Medical, Battery Powered | KYT | Class 1 | General Hospital | No | 2024-07-12 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2020-10-29 |
| Clip, Removable (Skin) | FZQ | Class 1 | General, Plastic Surgery | No | 2022-06-28 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2026-03-02 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2022-01-13 |
| Sunglasses (Non-Prescription Including Photosensitive) | HQY | Class 1 | Ophthalmic | No | 2020-09-07 |
| First Aid Kit Without Drug | OHO | Class 1 | General, Plastic Surgery | No | 2019-12-18 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2020-10-29 |
| Valve, Non-Rebreathing | CBP | Class 2 | Anesthesiology | No | 2020-10-25 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2021-12-12 |
| Depressor, Tongue, Non-Surgical | FMA | Class 1 | General Hospital | No | 2022-07-02 |
| Dressing, Compression | MHW | Class 1 | General Hospital | No | 2022-01-27 |
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2020-10-26 |
| Stethoscope, Manual | LDE | Class 1 | Cardiovascular | No | 2020-10-26 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2025-03-06 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2025-03-06 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2025-03-06 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2021-12-12 |
| Disinfectant, Medical Devices | LRJ | Class 1 | General Hospital | No | 2020-11-25 |
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 2019-12-17 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-04-07 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2020-11-17 |
| Crutch | IPR | Class 1 | Physical Medicine | No | 2022-02-17 |
| Skin Prep Tray | OJU | Class 1 | General, Plastic Surgery | No | 2025-06-11 |
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | QSY | Class U | Unknown | No | 2025-03-06 |
Proprietary Names
Silicone Massage Cup
Pressure Applying - Kangzhu Cupping Kit
Silicone Cupping Set
AIRWAY, NASOPHARYNGEAL
NASOPHARYNGEAL AIRWAY
Nitrile Gloves
Non-Sterile Blue Color
Patient Nitrile Examination Gloves
Powder Free
NON-CONTACT INFRARED THERMOMETER
NON-CONTACT DIGITAL THERMOMETER
IR Thermometer
JXB-178 Infrared Thermometer
Reusable Penlight
Disposable Penlight
Plastic Penlight
Aluminum Penlight
TAPE AND BANDAGE, ADHESIVE
Adhesive Bandages
Wound Closure Device
ZZIPS
ZZIPS CUT KIT
ZZIPS 2 PACK
Silver Alginate Dressing
Emergency Blanket
Emergency Foil Blanket
Emergency Space Blanket
Mylar Blanket
NON-PRESCRIPTION SUNGLASSES
Sunglasses with Impact Resistant Lenses
First Aid Kit without drug
Empty First Aid Box
First Aid Kit Bag with CPR Face Shield
Empty First Aid Bag
Metal First Aid Kit Box
OXYGEN MASK
CPR Face Shield
Face Shield
CPR Mask without Oxygen Port
Infant CPR Mask without Oxygen Port
CPR Mask with Oxygen Port
Non-Rebreathing Valve (18.5mm)
Non-Rebreathing Valve (15mmOD)
Gauze Pad
Medical Nitrile Glove
Polymer Patient Examination Glove
Non-Powdered Patient Examination Glove
Powder Free Nitrile Patient Examination Glove
Nitrile Glove
Tongue Depressor
Non-Surgical Tongue Depressor
Depressor
Compressed Krinkle Gauze
Compressed Gauze
Emergency Pressure Bandage
Blood Pressure Meter Model Max0203 (Blue, Pink or Black cuff)
Nitrile Patient Examination Glove
Nitrile Medical Glove
Elastic Bandage
Alcohol prep pad
Antiseptic wipes
Alcohol swab sticks
Antiseptic cleaning wipe
Oropharyngeal
Anesthesiology - Oropharyngeal Airway
Airway
Disposable Isolation Gowns
INSTANT COLD PACK
Disposable Hot or Cold Pack
Hot or Cold Pack Disposable
INSTANT HOT PACK
Aluminum Crutches
Skin Prep Tray
Zeolite Hemostatic Gauze
Hemostatic Gauze
Establishment Types
Export Device to the United States But Perform No Other Operation on Device