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
Phone
931 6254938

Products

Device Name Product Code
Handpiece, Direct Drive, Ac-Powered EKX

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