Hangzhou Singclean Medical Products Co Ltd
⚠️ Moderate Risk
FEI: 3010286405 • Hangzhou, Zhejiang • CHINA
FEI Number
3010286405
Location
Hangzhou, Zhejiang
Country
CHINAAddress
Economic & Technological Development Zon, No 125 (E) 10th Street, Hangzhoui, 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).
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.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
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).
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.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/4/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | Division of Southeast Imports (DSEI) | |
| 2/28/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | Division of Southeast Imports (DSEI) | |
| 11/19/2019 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 3/29/2018 | 53PY99OTHER COSMETIC RAW MATERIALS, N.E.C. | 237NO PMA | Division of Southeast Imports (DSEI) |
| 3/8/2018 | 53PY99OTHER COSMETIC RAW MATERIALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/15/2018 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 12/6/2017 | 78MRESOLUTION, SODIUM HYALURONATE | Division of Southeast Imports (DSEI) | |
| 10/20/2017 | 78MRESOLUTION, SODIUM HYALURONATE | Division of Southeast Imports (DSEI) | |
| 8/11/2017 | 78MRESOLUTION, SODIUM HYALURONATE | 237NO PMA | Division of Southeast Imports (DSEI) |
| 7/21/2017 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 237NO PMA | Division of Southeast Imports (DSEI) |
| 3/27/2017 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 237NO PMA | Detroit District Office (DET-DO) |
| 1/11/2016 | 53PH99OTHER COSMETIC RAW MATERIALS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 3/3/2015 | 89MOZACID, HYALURONIC, INTRAARTICULAR | Los Angeles District Office (LOS-DO) | |
| 4/9/2014 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Hangzhou Singclean Medical Products Co Ltd's FDA import refusal history?
Hangzhou Singclean Medical Products Co Ltd (FEI: 3010286405) has 14 FDA import refusal record(s) in our database, spanning from 4/9/2014 to 3/4/2022.
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 Products Co Ltd's FEI number is 3010286405.
What types of violations has Hangzhou Singclean Medical Products Co Ltd received?
Hangzhou Singclean Medical Products Co Ltd has been cited for 11 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 Products Co Ltd come from?
All FDA import refusal data for Hangzhou Singclean Medical Products 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.