Shantou Institute Of Ultasonic
⚠️ Moderate Risk
FEI: 3008252224 • Wan Chai, Hong Kong Island • HONG KONG
FEI Number
3008252224
Location
Wan Chai, Hong Kong Island
Country
HONG KONGAddress
2101 Lockhart Road, , Wan Chai, Hong Kong Island, Hong Kong
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 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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/11/2014 | 85KNGMONITOR, ULTRASONIC, FETAL | Florida District Office (FLA-DO) | |
| 6/13/2011 | 85KNGMONITOR, ULTRASONIC, FETAL | 508NO 510(K) | Florida District Office (FLA-DO) |
| 1/7/2011 | 85LQTDOPPLER ULTRASOUND FOR FETAL EVALUATION | Florida District Office (FLA-DO) | |
| 10/15/2010 | 85KNGMONITOR, ULTRASONIC, FETAL | Florida District Office (FLA-DO) | |
| 9/27/2010 | 85KNGMONITOR, ULTRASONIC, FETAL | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Shantou Institute Of Ultasonic's FDA import refusal history?
Shantou Institute Of Ultasonic (FEI: 3008252224) has 5 FDA import refusal record(s) in our database, spanning from 9/27/2010 to 7/11/2014.
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. Shantou Institute Of Ultasonic's FEI number is 3008252224.
What types of violations has Shantou Institute Of Ultasonic received?
Shantou Institute Of Ultasonic has been cited for 3 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 Shantou Institute Of Ultasonic come from?
All FDA import refusal data for Shantou Institute Of Ultasonic 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.