FDA Registration
Active
🇨🇳 China
Zhongshan Bisen Plastic Electronic Products Co.,Ltd
Reg #: 3038319732
·
FEI: 3038319732
·
Expires 2026
Products
9
Proprietary Names
14
Establishment Types
3
Classifications
9
Registration Details
- Registration Name
- Zhongshan Bisen Plastic Electronic Products Co.,Ltd
- Registration Number
- 3038319732
- FEI Number
- 3038319732
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3rd Floor, No. 5 Minyuan Road, Torch Development Zone
- City
- Zhongshan Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K212314
Owner / Operator
- Firm Name
- Zhongshan Bisen Plastic Electronic Products Co.,Ltd
- Operator Number
- 10093324
- Address
- 3rd Floor, No. 5 Minyuan Road, Torch Development Zone
- City
- Zhongshan
- State
- Guangdong
- Postal Code
- 528437
- Country
- CN
US Agent
- Business Name
- MEDRIGHT TECH INC
- Contact Name
- Jessie Yao
- Address
- 6302 FORT HAMILTON PARKWAY, 1R
- City
- Brooklyn
- State
- NY
- ZIP
- 11219
- Country
- US
- [email protected]
- Phone
- 718 2169957
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Light Based Over-The-Counter Hair Removal | OHT | Class 2 | General, Plastic Surgery | No | 2025-06-20 |
| Light Based Over The Counter Wrinkle Reduction | OHS | Class 2 | General, Plastic Surgery | No | 2025-06-20 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2025-04-29 |
| Brush, Dermabrasion, Powered | GFE | Class 1 | General, Plastic Surgery | No | 2025-04-29 |
| Cold Pack And Vibrating Massager | PHW | Class 1 | Physical Medicine | No | 2025-04-29 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2025-04-29 |
| Analyzer, Body Composition, Exempt | PUH | Class 2 | Cardiovascular | No | 2025-04-29 |
| Adaptor, Grooming | ILW | Class 1 | Physical Medicine | No | 2025-04-29 |
| Unit, Heating, Powered | IRQ | Class 1 | Physical Medicine | No | 2025-04-29 |
Proprietary Names
Hair Remover
RED Light Device
LED Red Therapy Light, Portable red light therapy,Red light wand,Red Light Therapy Device, Red Light Therapy Panel
Infrared Beauty Device, Infrared Skin Care Device, Therapeutic Heating,BZ-0610,BZ-0633,BZ-0512,BZ-0635,BZ-0609
Infrared Led Device,Led Heating Massage
Skin Scrubbert,Electric Facial Cleanser Set, Facial Cleanser,BZ-0719,BZ-0113
body slimming device,breast massage,,body massage BZ-0130,BZ-0130B,BZ-0131,BZ-0131B,BZ-0131E, BZ-0709,BZ-0709A,
BZ-0509,BZ-0512,BZ-0155
BZ-3029B
Eye Massage;Eye Therapy;Face Therapy;Facial Massage;Neck Therapy
Cellulite Massager,Body Sculpting Machine,EXT Spa, HAIR Spa, Massager,BZ-0610,BZ-0633,BZ-0512,BZ-0635,BZ-0609,BZ-3029A
Body Fat Analyzer,Body Fat Monitor
Blackhead Removal BZ-0702D & BZ-0708
Electric Hair Remover
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)