GE Medical Systems China Co., Ltd.
⚠️ Moderate Risk
FEI: 3003513129 • Wuxi, Jiangsu • CHINA
FEI Number
3003513129
Location
Wuxi, Jiangsu
Country
CHINAAddress
Dev. Zone, National Hi-Tech; No. 19 Changjiang Road; Xin, Wuxi, Jiangsu, 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).
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.
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.
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).
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 |
|---|---|---|---|
| 10/4/2021 | 90ITXTRANSDUCER, ULTRASONIC, DIAGNOSTIC | Division of Northern Border Imports (DNBI) | |
| 5/10/2021 | 79NRJULTRASOUND, SKIN PERMEATION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 9/1/2017 | 90IYNSYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC | Division of Northern Border Imports (DNBI) | |
| 9/1/2017 | 90IYNSYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC | Division of Northern Border Imports (DNBI) | |
| 10/24/2012 | 90IYNSYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC | Florida District Office (FLA-DO) | |
| 12/5/2006 | 74MHXMONITOR, PHYSIOLOGICAL, PATIENT | Minneapolis District Office (MIN-DO) | |
| 10/23/2006 | 74MHXMONITOR, PHYSIOLOGICAL, PATIENT | 47NON STD | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is GE Medical Systems China Co., Ltd.'s FDA import refusal history?
GE Medical Systems China Co., Ltd. (FEI: 3003513129) has 7 FDA import refusal record(s) in our database, spanning from 10/23/2006 to 10/4/2021.
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 Medical Systems China Co., Ltd.'s FEI number is 3003513129.
What types of violations has GE Medical Systems China Co., Ltd. received?
GE Medical Systems China 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 Medical Systems China Co., Ltd. come from?
All FDA import refusal data for GE Medical Systems China 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.