GE Hangwei Medical Systems, Co. Ltd.
⚠️ Moderate Risk
FEI: 3002175190 • Beijing, Beijing • CHINA
FEI Number
3002175190
Location
Beijing, Beijing
Country
CHINAAddress
West Area Bldg. 3, No.1 Yongchang North Road, Beijing Economic and Technological Development Zone, Beijing, Beijing, 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).
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 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).
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
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 |
|---|---|---|---|
| 1/19/2023 | 90MUEFULL FIELD DIGITAL, SYSTEM, X-RAY, MAMMOGRAPHIC | Division of Northern Border Imports (DNBI) | |
| 1/19/2023 | 90MUEFULL FIELD DIGITAL, SYSTEM, X-RAY, MAMMOGRAPHIC | Division of Northern Border Imports (DNBI) | |
| 1/19/2023 | 90MUEFULL FIELD DIGITAL, SYSTEM, X-RAY, MAMMOGRAPHIC | Division of Northern Border Imports (DNBI) | |
| 1/19/2023 | 90KPRSYSTEM, X-RAY, STATIONARY | Division of Northern Border Imports (DNBI) | |
| 2/29/2016 | 90IZLSYSTEM, X-RAY, MOBILE | Florida District Office (FLA-DO) | |
| 2/29/2016 | 90IXQTABLE, RADIOGRAPHIC, STATIONARY TOP | Florida District Office (FLA-DO) | |
| 2/29/2016 | 90IXJGRID, RADIOGRAPHIC | Florida District Office (FLA-DO) | |
| 2/29/2016 | 90IXJGRID, RADIOGRAPHIC | Florida District Office (FLA-DO) | |
| 2/6/2012 | 90KPWDEVICE, BEAM LIMITING, X-RAY, DIAGNOSTIC | Division of Southeast Imports (DSEI) | |
| 10/8/2010 | 90IXYHOLDER, RADIOGRAPHIC CASSETTE, WALL-MOUNTED | Chicago District Office (CHI-DO) | |
| 10/8/2010 | 90KPRSYSTEM, X-RAY, STATIONARY | Chicago District Office (CHI-DO) | |
| 5/19/2006 | 90IZHSYSTEM, X-RAY, MAMMOGRAPHIC | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is GE Hangwei Medical Systems, Co. Ltd.'s FDA import refusal history?
GE Hangwei Medical Systems, Co. Ltd. (FEI: 3002175190) has 12 FDA import refusal record(s) in our database, spanning from 5/19/2006 to 1/19/2023.
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. GE Hangwei Medical Systems, Co. Ltd.'s FEI number is 3002175190.
What types of violations has GE Hangwei Medical Systems, Co. Ltd. received?
GE Hangwei Medical Systems, Co. Ltd. has been cited for 6 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 GE Hangwei Medical Systems, Co. Ltd. come from?
All FDA import refusal data for GE Hangwei Medical Systems, 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.