FDA Registration
Active
🇨🇳 China
Ultrasonic Scaler, P7,B5,B5S,B5L,P4,P5,P5L,B6,B6S,B6L,P6,P7L,P9,P9L,C5,C5S,C5L,C6,C7,C7L
Reg #: 3008615394
·
FEI: 3008615394
·
Expires 2025
Products
1
Proprietary Names
8
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- NANNING BAOLAI MEDICAL INSTRUMENT CO., LTD
- Registration Number
- 3008615394
- FEI Number
- 3008615394
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 7th FLOOR, GENERAL BUILDING,, HETAI SCI.&TECH. PARK,9 GAOXIN 4th RD
- City
- NANNING Guangxi
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K140233
Owner / Operator
- Firm Name
- NANNING BAOLAI MEDICAL INSTRUMENT CO., LTD
- Operator Number
- 10049130
- Address
- 7th FLOOR, GENERAL BUILDING,, HETAI SCI.&TECH. PARK,9 GAOXIN 4th RD
- City
- NANNING
- State
- Guangxi
- Postal Code
- 530007
- Country
- CN
- Correspondent
- Wanqing Bi
US Agent
- Business Name
- IRC USA
- Contact Name
- Charles Mack
- Address
- 2950 E Lindrick Dr
- City
- Chandler
- State
- AZ
- ZIP
- 85249
- Country
- US
- [email protected]
- Phone
- 931 6254938
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Scaler, Ultrasonic | ELC | Class 2 | Dental | No | 2015-04-17 |
Proprietary Names
Ultrasonic Scaler, P7,B5,B5S,B5L,P4,P5,P5L,B6,B6S,B6L,P6,P7L,P9,P9L,C5,C5S,C5L,C6,C7,C7L
BD2
CD1; CD2 ;CD3
P9-2
RH1,RHS,RH2,RH3,RL1,RL3,RD1,RD2,RD3,RP1,RP2,RP3,RP4,RP5
K10
P8L,MPT1
GL5,GL5L
Establishment Types
Manufacture Medical Device