Guangzhou Chuangqi Medical Equipmen
⚠️ Moderate Risk
FEI: 3009152971 • Guangzhou • CHINA
FEI Number
3009152971
Location
Guangzhou
Country
CHINAAddress
90 Zijing St. Hejing Roaddongsha,, , Guangzhou, , China
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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
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.
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).
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.
NO PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/3/2012 | 76EMNSCALER, PERIODONTIC | Los Angeles District Office (LOS-DO) | |
| 1/3/2012 | 76JERCLEANER, DENTURE, MECHANICAL | Los Angeles District Office (LOS-DO) | |
| 1/3/2012 | 95RGOUV CURING, NONCOHERENT LIGHT SOURCE, ULTRAVIOLET COMMERCIAL/CONSUMER | Los Angeles District Office (LOS-DO) | |
| 1/3/2012 | 76EAPUNIT, X-RAY, INTRAORAL | Los Angeles District Office (LOS-DO) | |
| 1/3/2012 | 76LQYLOCATOR, ROOT APEX | Los Angeles District Office (LOS-DO) | |
| 1/3/2012 | 76KOKSTERILIZER, ENDODONTIC DRY HEAT | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Guangzhou Chuangqi Medical Equipmen's FDA import refusal history?
Guangzhou Chuangqi Medical Equipmen (FEI: 3009152971) has 6 FDA import refusal record(s) in our database, spanning from 1/3/2012 to 1/3/2012.
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. Guangzhou Chuangqi Medical Equipmen's FEI number is 3009152971.
What types of violations has Guangzhou Chuangqi Medical Equipmen received?
Guangzhou Chuangqi Medical Equipmen 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 Guangzhou Chuangqi Medical Equipmen come from?
All FDA import refusal data for Guangzhou Chuangqi Medical Equipmen 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.