Hangzhou Singclean Medical Produ
⚠️ Moderate Risk
FEI: 3009492567 • Hangzhou, Zhejiang • CHINA
FEI Number
3009492567
Location
Hangzhou, Zhejiang
Country
CHINAAddress
No 188 Gao Giao West Road, , Hangzhou, Zhejiang, 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
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/18/2012 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 237NO PMA | New Orleans District Office (NOL-DO) |
| 6/18/2012 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 237NO PMA | New Orleans District Office (NOL-DO) |
| 5/25/2012 | 78MRESOLUTION, SODIUM HYALURONATE | 237NO PMA | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Hangzhou Singclean Medical Produ's FDA import refusal history?
Hangzhou Singclean Medical Produ (FEI: 3009492567) has 3 FDA import refusal record(s) in our database, spanning from 5/25/2012 to 6/18/2012.
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. Hangzhou Singclean Medical Produ's FEI number is 3009492567.
What types of violations has Hangzhou Singclean Medical Produ received?
Hangzhou Singclean Medical Produ has been cited for 1 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 Hangzhou Singclean Medical Produ come from?
All FDA import refusal data for Hangzhou Singclean Medical Produ 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.