Ningbo David Medical Device Co.,Ltd
⚠️ Moderate Risk
FEI: 3003307657 • Ningbo, Zhejiang • CHINA
FEI Number
3003307657
Location
Ningbo, Zhejiang
Country
CHINAAddress
# 2 Keyuan Road, Shipuzhen Xiangshan Xian, Ningbo, 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
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.
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).
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.
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/21/2014 | 80FPLINCUBATOR, NEONATAL TRANSPORT | Florida District Office (FLA-DO) | |
| 7/18/2014 | 80FPLINCUBATOR, NEONATAL TRANSPORT | Division of Southeast Imports (DSEI) | |
| 3/5/2014 | 80FMTWARMER, INFANT RADIANT | 341REGISTERED | Florida District Office (FLA-DO) |
| 1/2/2014 | 80FMTWARMER, INFANT RADIANT | Florida District Office (FLA-DO) | |
| 11/29/2013 | 80FMTWARMER, INFANT RADIANT | Florida District Office (FLA-DO) | |
| 10/15/2013 | 80FPLINCUBATOR, NEONATAL TRANSPORT | Florida District Office (FLA-DO) | |
| 10/24/2012 | 80FMZINCUBATOR, NEONATAL | Division of Southeast Imports (DSEI) | |
| 10/2/2012 | 80FMTWARMER, INFANT RADIANT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/2/2012 | 80FMZINCUBATOR, NEONATAL | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 8/9/2012 | 80FMTWARMER, INFANT RADIANT | Florida District Office (FLA-DO) | |
| 6/18/2012 | 80FMTWARMER, INFANT RADIANT | Florida District Office (FLA-DO) | |
| 6/18/2012 | 80FMZINCUBATOR, NEONATAL | Florida District Office (FLA-DO) | |
| 6/18/2012 | 80FMZINCUBATOR, NEONATAL | Florida District Office (FLA-DO) | |
| 6/18/2012 | 80FMZINCUBATOR, NEONATAL | Florida District Office (FLA-DO) | |
| 4/20/2012 | 80FMTWARMER, INFANT RADIANT | Florida District Office (FLA-DO) | |
| 4/19/2012 | 80FMTWARMER, INFANT RADIANT | Florida District Office (FLA-DO) | |
| 3/28/2012 | 80KMIMONITOR, BED PATIENT | 476NO REGISTR | Division of Southeast Imports (DSEI) |
| 1/23/2012 | 80FMTWARMER, INFANT RADIANT | Florida District Office (FLA-DO) | |
| 1/23/2012 | 80FMZINCUBATOR, NEONATAL | Florida District Office (FLA-DO) | |
| 11/17/2011 | 80KMIMONITOR, BED PATIENT | 341REGISTERED | Florida District Office (FLA-DO) |
| 11/15/2011 | 80FMTWARMER, INFANT RADIANT | Division of Southeast Imports (DSEI) | |
| 9/22/2011 | 80FMTWARMER, INFANT RADIANT | 508NO 510(K) | Florida District Office (FLA-DO) |
| 9/19/2011 | 80FMTWARMER, INFANT RADIANT | Florida District Office (FLA-DO) | |
| 8/1/2011 | 80FMTWARMER, INFANT RADIANT | 341REGISTERED | Florida District Office (FLA-DO) |
| 3/25/2011 | 80FMZINCUBATOR, NEONATAL | Florida District Office (FLA-DO) | |
| 3/25/2011 | 80LBIUNIT, NEONATAL PHOTOTHERAPY | Florida District Office (FLA-DO) | |
| 3/25/2011 | 80FMTWARMER, INFANT RADIANT | Florida District Office (FLA-DO) | |
| 2/3/2011 | 80FMTWARMER, INFANT RADIANT | 118NOT LISTED | Florida District Office (FLA-DO) |
| 2/3/2011 | 73FOGHOOD, OXYGEN, INFANT | 118NOT LISTED | Florida District Office (FLA-DO) |
| 7/8/2010 | 80KMIMONITOR, BED PATIENT | Florida District Office (FLA-DO) | |
| 7/8/2010 | 80FMZINCUBATOR, NEONATAL | Florida District Office (FLA-DO) | |
| 3/25/2010 | 80FNLBED, AC-POWERED ADJUSTABLE HOSPITAL | Florida District Office (FLA-DO) | |
| 3/25/2010 | 80FMTWARMER, INFANT RADIANT | Florida District Office (FLA-DO) | |
| 3/25/2010 | 80FMZINCUBATOR, NEONATAL | Florida District Office (FLA-DO) | |
| 1/25/2010 | 80KMIMONITOR, BED PATIENT | Florida District Office (FLA-DO) | |
| 1/25/2010 | 80FMTWARMER, INFANT RADIANT | Florida District Office (FLA-DO) | |
| 9/23/2009 | 80FMZINCUBATOR, NEONATAL | Division of Southeast Imports (DSEI) | |
| 8/5/2009 | 80FMZINCUBATOR, NEONATAL | Division of Southeast Imports (DSEI) | |
| 8/29/2008 | 80FPLINCUBATOR, NEONATAL TRANSPORT | Division of Southeast Imports (DSEI) | |
| 8/6/2007 | 80FMZINCUBATOR, NEONATAL | 341REGISTERED | Florida District Office (FLA-DO) |
| 10/31/2006 | 80FMZINCUBATOR, NEONATAL | Florida District Office (FLA-DO) | |
| 6/5/2006 | 80FMZINCUBATOR, NEONATAL | Division of Southeast Imports (DSEI) | |
| 5/24/2006 | 80FMZINCUBATOR, NEONATAL | Florida District Office (FLA-DO) | |
| 11/8/2005 | 80FMZINCUBATOR, NEONATAL | Division of Southeast Imports (DSEI) | |
| 7/12/2004 | 80FMZINCUBATOR, NEONATAL | Division of Southeast Imports (DSEI) | |
| 3/23/2004 | 80FMZINCUBATOR, NEONATAL | Division of Southeast Imports (DSEI) | |
| 3/9/2004 | 80FMZINCUBATOR, NEONATAL | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Ningbo David Medical Device Co.,Ltd's FDA import refusal history?
Ningbo David Medical Device Co.,Ltd (FEI: 3003307657) has 47 FDA import refusal record(s) in our database, spanning from 3/9/2004 to 8/21/2014.
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. Ningbo David Medical Device Co.,Ltd's FEI number is 3003307657.
What types of violations has Ningbo David Medical Device Co.,Ltd received?
Ningbo David Medical Device Co.,Ltd has been cited for 5 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 Ningbo David Medical Device Co.,Ltd come from?
All FDA import refusal data for Ningbo David Medical Device 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.