Guilin Woodpecker Medical Instrument Co., Ltd.
⚠️ High Risk
FEI: 3005581016 • Guilin, Guangxi • CHINA
FEI Number
3005581016
Location
Guilin, Guangxi
Country
CHINAAddress
Information Industrial Park, National High-Tech Zone, Guilin, Guangxi, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/23/2025 | 90EHDUNIT, X-RAY, EXTRAORAL WITH TIMER | Division of Southeast Imports (DSEI) | |
| 6/6/2022 | 76EKXHANDPIECE, DIRECT DRIVE, AC-POWERED | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 6/6/2022 | 76EBZACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 6/6/2022 | 76LQYLOCATOR, ROOT APEX | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 6/6/2022 | 76EBZACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 6/6/2022 | 76ELCSCALER, ULTRASONIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 6/6/2022 | 90MUHSYSTEM, X-RAY, EXTRAORAL SOURCE, DIGITAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/20/2021 | 76EKRPLUGGER, ROOT CANAL, ENDODONTIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 6/29/2021 | 78FECOBTURATOR, FOR ENDOSCOPE | Division of Southeast Imports (DSEI) | |
| 9/9/2019 | 76ELCSCALER, ULTRASONIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/10/2019 | 76LQYLOCATOR, ROOT APEX | Division of Southeast Imports (DSEI) | |
| 9/7/2018 | 76ELCSCALER, ULTRASONIC | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 3/13/2018 | 76LQYLOCATOR, ROOT APEX | Division of Southeast Imports (DSEI) | |
| 10/10/2017 | 80FLGCLEANER, ULTRASONIC, MEDICAL INSTRUMENT | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 1/30/2015 | 76EBZACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Guilin Woodpecker Medical Instrument Co., Ltd.'s FDA import refusal history?
Guilin Woodpecker Medical Instrument Co., Ltd. (FEI: 3005581016) has 15 FDA import refusal record(s) in our database, spanning from 1/30/2015 to 9/23/2025.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Guilin Woodpecker Medical Instrument Co., Ltd.'s FEI number is 3005581016.
What types of violations has Guilin Woodpecker Medical Instrument Co., Ltd. received?
Guilin Woodpecker Medical Instrument Co., Ltd. has been cited for 6 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Guilin Woodpecker Medical Instrument Co., Ltd. come from?
All FDA import refusal data for Guilin Woodpecker Medical Instrument Co., Ltd. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.