FDA Registration
Active
🇨🇳 China
LED.E;LED.F;LED.H;LUX V, LUX E
Reg #: 3005581016
·
FEI: 3005581016
·
Expires 2025
Products
1
Proprietary Names
14
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
- K080025
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 |
|---|---|---|---|---|---|
| Activator, Ultraviolet, For Polymerization | EBZ | Class 2 | Dental | No | 2008-03-25 |
Proprietary Names
LED.E;LED.F;LED.H;LUX V, LUX E
LUX VI
O-Light
i Led
X-Cure
B-Cure
O-Star
LED.G
LED.B;LED.C,LED.D
Dental Curing Light
O-Light II
iLed II
V V Light
X-Star
Establishment Types
Manufacture Medical Device