CHISON Medical Technologies Co., Ltd.
⚠️ Moderate Risk
FEI: 3004753388 • Wuxi, Jiangsu • CHINA
FEI Number
3004753388
Location
Wuxi, Jiangsu
Country
CHINAAddress
No.228, Changjiang East Road, Block 51 and 53, Phase 5, Shuofang Industrial Park, Xinwu District, No.9, Xinhuihuan Road, Xinwu District, 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
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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.
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/26/2023 | 90IYOSYSTEM, IMAGING, PULSED ECHO, ULTRASONIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/31/2017 | 90IYNSYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 12/2/2014 | 90IYOSYSTEM, IMAGING, PULSED ECHO, ULTRASONIC | 16DIRECTIONS | Los Angeles District Office (LOS-DO) |
| 11/3/2014 | 90IYOSYSTEM, IMAGING, PULSED ECHO, ULTRASONIC | 16DIRECTIONS | Los Angeles District Office (LOS-DO) |
| 9/8/2014 | 90ITXTRANSDUCER, ULTRASONIC, DIAGNOSTIC | Los Angeles District Office (LOS-DO) | |
| 4/7/2014 | 90IYOSYSTEM, IMAGING, PULSED ECHO, ULTRASONIC | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 7/2/2012 | 85LXEFETAL DOPPLER ULTRASOUND | Florida District Office (FLA-DO) | |
| 6/21/2012 | 85LXEFETAL DOPPLER ULTRASOUND | Florida District Office (FLA-DO) | |
| 6/21/2012 | 85LXEFETAL DOPPLER ULTRASOUND | Florida District Office (FLA-DO) | |
| 2/16/2012 | 90MJSCONTRAST MEDIA, ULTRASOUND | 341REGISTERED | Florida District Office (FLA-DO) |
| 2/16/2012 | 90MJSCONTRAST MEDIA, ULTRASOUND | 341REGISTERED | Florida District Office (FLA-DO) |
| 6/13/2011 | 90MJSCONTRAST MEDIA, ULTRASOUND | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/26/2011 | 90LQTDOPPLER ULTRASOUND FOR FETAL EVALUATION | Florida District Office (FLA-DO) | |
| 9/21/2005 | 85LQTDOPPLER ULTRASOUND FOR FETAL EVALUATION | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is CHISON Medical Technologies Co., Ltd.'s FDA import refusal history?
CHISON Medical Technologies Co., Ltd. (FEI: 3004753388) has 14 FDA import refusal record(s) in our database, spanning from 9/21/2005 to 7/26/2023.
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. CHISON Medical Technologies Co., Ltd.'s FEI number is 3004753388.
What types of violations has CHISON Medical Technologies Co., Ltd. received?
CHISON Medical Technologies 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 CHISON Medical Technologies Co., Ltd. come from?
All FDA import refusal data for CHISON Medical Technologies 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.