FDA Registration
Active
🇨🇳 China
GUANGDONG DEXIN SPORTS INDUSTRY CO.,LTD
Reg #: 3014167550
·
FEI: 3014167550
·
Expires 2026
Products
13
Proprietary Names
18
Establishment Types
4
Classifications
13
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Registration Details
- Registration Name
- GUANGDONG DEXIN SPORTS INDUSTRY CO.,LTD
- Registration Number
- 3014167550
- FEI Number
- 3014167550
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Xinzhuang Section, Furong Road, Huadu District
- City
- Guangzhou Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K160802
Owner / Operator
- Firm Name
- GUANGDONG DEXIN SPORTS INDUSTRY CO.,LTD
- Operator Number
- 10086739
- Address
- Xinzhuang Section, Furong Road, Huadu District
- City
- Guangzhou
- State
- Guangdong
- Postal Code
- 510850
- Country
- CN
- Correspondent
- Tony Tang
US Agent
- Business Name
- SOUTH BAY INNOVATION LLC
- Contact Name
- Yueting Zhu
- Address
- 23545 Crenshaw Blvd Ste 106
- City
- Torrance
- State
- CA
- ZIP
- 90505
- Country
- US
- [email protected]
- Phone
- 424 3769142
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Strip, Temperature, Forehead, Liquid Crystal | KPD | Class 2 | General Hospital | No | 2022-12-07 |
| Sunglasses (Non-Prescription Including Photosensitive) | HQY | Class 1 | Ophthalmic | No | 2022-12-07 |
| Shield, Eye, Radiological | IWS | Class 1 | Radiology | No | 2022-12-19 |
| Lens, Spectacle, Non-Custom (Prescription) | HQG | Class 1 | Ophthalmic | No | 2022-12-19 |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | Class 1 | Anesthesiology | No | 2023-03-02 |
| Mask, Scavenging | KHA | Class 1 | Anesthesiology | No | 2022-12-07 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2022-12-07 |
| Respirator, Surgical | MSH | Class 2 | General, Plastic Surgery | No | 2022-12-19 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2022-12-07 |
| Barrier Face Covering Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy | QOZ | Class N | Unknown | No | 2023-03-02 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2022-12-07 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2022-12-07 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2022-12-07 |
Proprietary Names
forehead thermometer gun
Bluetooth glasses Q-VT9,Q-VT10 ,Q-VT11,Q-VT12,Q-VT13,QVT14,Q-VT15,Q-VT16,Q-VT17,Q-VT18, DEX19,DEX20,DEX21,DEX22,DEX23
Sun glasses
DEX24,DEX25,DEX26,DEX27,DEX28
Radiation glasses
Myopic glasses; Presbyopic glasses
Snorkel
Masks Scavenging; Protective face shield SP06
Cover, shoe, operating- room
KN95 mask
CAP SURGICAL
Full Face Mask
SKI GOGGLES
Bevo Comfort PPE Goggle White S/M, L/XL
Diving Mask
Swimming Goggles
Protective goggles SP01, SP02, SP05, YH12, DEX-F06,DEX-F07
Gown
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device
Remanufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)