Shanghai Smedent Medical Instrument Co., Ltd.
⚠️ Moderate Risk
FEI: 3008370577 • Shanghai, Shanghai • CHINA
FEI Number
3008370577
Location
Shanghai, Shanghai
Country
CHINAAddress
Bldg. 10 Th Suite 310, 3599 Qixin Rd, Shanghai, Shanghai, 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).
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.
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/21/2012 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Division of Southeast Imports (DSEI) | |
| 7/26/2011 | 76ELCSCALER, ULTRASONIC | Seattle District Office (SEA-DO) | |
| 7/26/2011 | 76EFNCOTTON, ROLL | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Shanghai Smedent Medical Instrument Co., Ltd.'s FDA import refusal history?
Shanghai Smedent Medical Instrument Co., Ltd. (FEI: 3008370577) has 3 FDA import refusal record(s) in our database, spanning from 7/26/2011 to 2/21/2012.
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. Shanghai Smedent Medical Instrument Co., Ltd.'s FEI number is 3008370577.
What types of violations has Shanghai Smedent Medical Instrument Co., Ltd. received?
Shanghai Smedent Medical Instrument Co., Ltd. has been cited for 4 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 Shanghai Smedent Medical Instrument Co., Ltd. come from?
All FDA import refusal data for Shanghai Smedent 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.