Shenzhen Yimi Life Technology Co., Ltd
⚠️ High Risk
FEI: 3016171841 • Shenzhen, Guangdong • CHINA
FEI Number
3016171841
Location
Shenzhen, Guangdong
Country
CHINAAddress
306,Tengbo Industrial Park,Changshangjiang Street,Longbei Village,Pingshan New District, , Shenzhen, Guangdong, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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.
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).
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 |
|---|---|---|---|
| 1/2/2025 | 73DQAOXIMETER | Division of West Coast Imports (DWCI) | |
| 3/3/2022 | 73DQAOXIMETER | Division of Southeast Imports (DSEI) | |
| 1/26/2021 | 73DQAOXIMETER | Division of Southeast Imports (DSEI) | |
| 8/20/2020 | 73QLSPULSE OXIMETER FOR LOW-ACUITY SETTINGS | Division of Southeast Imports (DSEI) | |
| 8/4/2020 | 73DQAOXIMETER | Division of Southeast Imports (DSEI) | |
| 8/3/2020 | 73DQAOXIMETER | Division of Southeast Imports (DSEI) | |
| 7/24/2020 | 81GLYOXIMETER TO MEASURE HEMOGLOBIN | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 7/17/2020 | 74DQECATHETER, OXIMETER, FIBEROPTIC | Division of Southeast Imports (DSEI) | |
| 7/16/2020 | 73DQAOXIMETER | Division of Southeast Imports (DSEI) | |
| 7/16/2020 | 73DQAOXIMETER | Division of Southeast Imports (DSEI) | |
| 7/16/2020 | 73DQAOXIMETER | Division of Southeast Imports (DSEI) | |
| 7/16/2020 | 73DQAOXIMETER | Division of Southeast Imports (DSEI) | |
| 7/2/2020 | 73DQAOXIMETER | Division of Southeast Imports (DSEI) | |
| 6/18/2020 | 73DQAOXIMETER | Division of Southeast Imports (DSEI) | |
| 6/15/2020 | 73DQAOXIMETER | Division of Southeast Imports (DSEI) | |
| 6/2/2020 | 73DQAOXIMETER | Division of Southeast Imports (DSEI) | |
| 6/2/2020 | 73DQAOXIMETER | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Shenzhen Yimi Life Technology Co., Ltd's FDA import refusal history?
Shenzhen Yimi Life Technology Co., Ltd (FEI: 3016171841) has 17 FDA import refusal record(s) in our database, spanning from 6/2/2020 to 1/2/2025.
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. Shenzhen Yimi Life Technology Co., Ltd's FEI number is 3016171841.
What types of violations has Shenzhen Yimi Life Technology Co., Ltd received?
Shenzhen Yimi Life Technology Co., Ltd has been cited for 4 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 Shenzhen Yimi Life Technology Co., Ltd come from?
All FDA import refusal data for Shenzhen Yimi Life Technology 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.