FDA Registration
Active
🇨🇳 China
Motopex, Endo Matic, Endo Smart+, E-Com+
Reg #: 3005581016
·
FEI: 3005581016
·
Expires 2025
Products
1
Proprietary Names
11
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD
- Registration Number
- 3005581016
- FEI Number
- 3005581016
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Information Industrial Park, Guilin National High-Tech Zone
- City
- GUILIN CITY Guangxi
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K203320
Owner / Operator
- Firm Name
- GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD
- Operator Number
- 9080879
- Address
- Information Industrial Park, Guilin National High-Tech Zone
- City
- GUILIN
- State
- Guangxi
- Postal Code
- 541004
- Country
- CN
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 |
|---|---|---|---|---|---|
| Handpiece, Direct Drive, Ac-Powered | EKX | Class 1 | Dental | No | 2021-05-13 |
Proprietary Names
Motopex, Endo Matic, Endo Smart+, E-Com+
Endo Motor, Ai- Motor, Endo Radar Plus
Endo Radar Pro, Endo Smart
ACE
Smart A, Endo Pace, Endo Free, BAE380R
Endo Motor, EDGEAPEX HP
E-COM, Endo Radar
Endo Motor, CanalPro X-Move
EndoPro Ai1
Endo Space
812 MT
Establishment Types
Manufacture Medical Device