FDA Registration
Active
🇨🇳 China
SHANDONG HUAMEI TECHNOLOGY CO.,LTD.
Reg #: 3016170453
·
FEI: 3016170453
·
Expires 2026
Products
5
Proprietary Names
26
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- SHANDONG HUAMEI TECHNOLOGY CO.,LTD.
- Registration Number
- 3016170453
- FEI Number
- 3016170453
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 588,Changning Street,High-tech District
- City
- Weifang Shandong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K202758
Owner / Operator
- Firm Name
- Shandong Huamei Technology Co Ltd
- Operator Number
- 10061692
- Address
- 588,Changning Street,High-tech District
- City
- Weifang
- State
- Shandong
- Postal Code
- 261205
- Country
- CN
- Correspondent
- Qinghua Xu
US Agent
- Business Name
- Believe-Med Technical Service Inc.
- Contact Name
- Wen Xu
- Address
- 4611 Maydew Mews Way
- City
- Ellicott
- State
- MD
- ZIP
- 21042
- Country
- US
- [email protected]
- Phone
- 443 8968583
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2020-11-24 |
| Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | ONF | Class 2 | General, Plastic Surgery | No | 2019-12-20 |
| Brush, Dermabrasion, Powered | GFE | Class 1 | General, Plastic Surgery | No | 2020-06-04 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2020-06-05 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2025-02-26 |
Proprietary Names
Zemits YAGenix
Nd: YAG Laser Therapy Systems HM-YL900
Diode Laser Hair Removal System HM-DL100
Diode Laser Hair Removal System HM-DL300
Diode Laser Hair Removal System HM-DL800
Diode Laser Hair Removal System HM-DL900
Diode Laser Hair Removal System HM-DL600
Diode Laser Hair Removal System HM-DL200
Diode Laser Hair Removal System HM-DL220
Intense Pulsed Light Treatment System, Model: HM-IPL-B8, HM-IPL-B3, HM-IPL-J1, HM-IPL-J2, HM-IPL-YA, HM-IPL-YB6
Intense Pulsed Light Treatment System EROSE-YB6
Intense Pulsed Light Treatment System EROSE-YA
Facial Management System,Model:OV-2000 (OxyVERVE), OV-3000 (OxyVERVE)
Beauty System HM-PL200
Beauty System HM-PL300
Beauty System HM-PL100
Beauty System HM-PL600
Facial Management System, Model:JM-M1, JM-M2, JM-M3, JM-M4, JM-M5, JM-M6, JM-M7, JM-M8
CO2 Laser Therapy System HM-CL200
Inner ball roller massage machine HM-GL100 HM-GL300 HM-GL600 HM-GL660 HM-GL880
Photodynamic Therapy (PDT) Equipment HM-PDT 200
Photodynamic Therapy (PDT) Equipment HM-PDT 500
Zemits LumaGenix
Photodynamic Therapy (PDT) Equipment HM-PDT 900
Photodynamic Therapy (PDT) Equipment HM-PDT 100
EMS Sculpt Machine(HM-EMS900)
Establishment Types
Manufacture Medical Device