Shanghai Dway International
⚠️ Moderate Risk
FEI: 3004485664 • Kowloon • HONG KONG
FEI Number
3004485664
Location
Kowloon
Country
HONG KONGAddress
Suite 906, O/f, Ocean Centre Harbour, , Kowloon, , 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
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/7/2004 | 79FWZACCESSORIES, OPERATING-ROOM, TABLE (KIT) | Division of Southeast Imports (DSEI) | |
| 3/31/2004 | 74DPSELECTROCARDIOGRAPH | 341REGISTERED | Florida District Office (FLA-DO) |
| 3/31/2004 | 80KZHINTRODUCER, SYRINGE NEEDLE | 341REGISTERED | Florida District Office (FLA-DO) |
| 3/31/2004 | 73BSRSTYLET, TRACHEAL TUBE | 341REGISTERED | Florida District Office (FLA-DO) |
| 3/31/2004 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 341REGISTERED | Florida District Office (FLA-DO) |
| 3/31/2004 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 341REGISTERED | Florida District Office (FLA-DO) |
| 3/31/2004 | 90IZLSYSTEM, X-RAY, MOBILE | 341REGISTERED | Florida District Office (FLA-DO) |
| 3/31/2004 | 86HJOBIOMICROSCOPE, SLIT-LAMP, AC-POWERED | 341REGISTERED | Florida District Office (FLA-DO) |
| 3/31/2004 | 80MIOLIGHT, THERAPY, SAD(SEASONAL AFFECTIVE DISORDER) | 341REGISTERED | Florida District Office (FLA-DO) |
| 3/31/2004 | 85LXEFETAL DOPPLER ULTRASOUND | 341REGISTERED | Florida District Office (FLA-DO) |
| 3/31/2004 | 74LDESTETHOSCOPE, MANUAL | 341REGISTERED | Florida District Office (FLA-DO) |
| 3/31/2004 | 79LWGSURGICAL TABLE CUSHION | 341REGISTERED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Shanghai Dway International's FDA import refusal history?
Shanghai Dway International (FEI: 3004485664) has 12 FDA import refusal record(s) in our database, spanning from 3/31/2004 to 4/7/2004.
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 Dway International's FEI number is 3004485664.
What types of violations has Shanghai Dway International received?
Shanghai Dway International 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 Shanghai Dway International come from?
All FDA import refusal data for Shanghai Dway International 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.