FDA Registration
Active
🇨🇳 China
Lamp infrared, Therapeutic Heating, 5F300A
Reg #: 3013995763
·
FEI: 3013995763
·
Expires 2025
Products
1
Proprietary Names
19
Establishment Types
5
Classifications
1
Registration Details
- Registration Name
- SHENZHEN HANHUA OPTO CO., LTD.
- Registration Number
- 3013995763
- FEI Number
- 3013995763
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5F, Building A, YIshida Bao Yicheng Science and Technology park, Guanlan Street, Longhua District, Shenzhen
- City
- shenzhen Guangdong
- Country
- CN
Owner / Operator
- Firm Name
- Shenzhen Hanhua Opto Co., Ltd.
- Operator Number
- 10083913
- Address
- 5F, Building A, YIshida Bao Yicheng Science and Technology park, Guanlan Street, Longhua District, Shenzhen
- City
- shenzhen
- State
- Guangdong
- Postal Code
- 518000
- Country
- CN
- Correspondent
- Taishan Wu
US Agent
- Business Name
- SOUTH BAY INNOVATION LLC
- Contact Name
- Yueting Zhu
- Address
- 23545 Crenshaw Blvd #102 Torrance CA 90505
- City
- Torrance
- State
- CA
- ZIP
- 90505
- Country
- US
- [email protected]
- Phone
- 424 3769142
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2021-12-30 |
Proprietary Names
Lamp infrared, Therapeutic Heating, 5F300A
Lamp infrared, Therapeutic Heating, COB500PRO ,COB500-B2PLUS,COB500-C,COB500-B3,COB500-B3(UVB&UVA),COB500-C1
Lamp,Infrared,Therapeutic Heating,YD120,YD240,YD360,FP300plus, FP1000plus,FP1500plus,P300plus,P1000plus,COB236,COB248
COB1400Pro,COB4425,COB5300,RTL15,RLBE25, PAR38-54,XF45,5F300,RH110,LED Therapy Light,Red Light Therapy
Torch,Red Light Therapy Bulbs,Red Light Hair Cap,Red Light Therapy Hands,Red Light Therapy Slipper
COB500, RTLT15,PAR38-24,PAR38-36,PAR38-54,XF45,LED Therapy Light,Red Light Therapy,Red Light Therapy Pad
Red Light Therapy Panel,Red Light Therapy Wraps,
Brand: GERLOVE, HKE
Red Light Therapy Pad,Red Light Physiontherapy Flashlight,Red Light Therapy Bulbs,Red Light Hair Cap
Lamp,Infrared,TherapeuticHeating,YD120,YD240,FP150plus,FP300plus,FP1000plus,FP1500plus,P300plus,P1000plus,HP600Pro
Red Light Therapy Hands,Red Light Therapy Slipper
Lamp infrared, Therapeutic Heating, HP1200PRO, HP3600, HP1800PRO, HP600PRO, FP1500PLUS
HP1200Pro,HP1800Pro,HP6000Pro,COB236Plus,COB248,COB260Pro,COB500Plus,COB770Plus,COB1060Plus,COB1400Plus
Lamp infrared, Therapeutic Heating, RH102, RH88, YD288, YD1540, YD3264, YD156, YD198, YD660
Lamp infrared, Therapeutic Heating, COB1400-B2PRO,MINI60,MINI100,P600,COB4425PLUS(UVB&UVA)
Lamp infrared, Therapeutic Heating, COB1400-B3, COB1400-B1PRO, COB1400-B3(UAB&UVB), COB1400-B2PRO
Lamp infrared, Therapeutic Heating, COB924PLUS,COB520,COB1320-C,COB1400-B3,COB1400-B1PRO,COB1400-B3(UAB&UVB)
Lamp infrared, Therapeutic Heating, P1200PLUS,COB236,COB500,COB1400,COB260,COB248
Lamp infrared, Therapeutic Heating, COB500-C2,COB1320plus,UV606,UV1612,ULTRON,HP5400PLUS,COB976PLUS,COB5300PLUS
Establishment Types
Remanufacture Medical Device
Repack or Relabel Medical Device
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device