FDA Registration
Active
🇨🇳 China
Ultrasonic Endo Activation Device (Model: Actor I pro)
Reg #: 3017618678
·
FEI: 3017618678
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- CHANGZHOU BOMEDENT MEDICAL TECHNOLOGY CO., LTD
- Registration Number
- 3017618678
- FEI Number
- 3017618678
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- NO.9 Changyang road, West Taihu Science Techology Industrial Park
- City
- Changzhou Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K213947
Owner / Operator
- Firm Name
- ChangZhou BoMedent Medical Technology Co., Ltd
- Operator Number
- 10078266
- Address
- NO.9 Changyang road, West Taihu Science Techology Industrial Park
- City
- Changzhou
- State
- Jiangsu
- Postal Code
- 213100
- 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 |
|---|---|---|---|---|---|
| Scaler, Ultrasonic | ELC | Class 2 | Dental | No | 2022-09-12 |
Proprietary Names
Ultrasonic Endo Activation Device (Model: Actor I pro)
Establishment Types
Manufacture Medical Device