Shenzhen Imdk Medical Technology Co., Ltd.
⚠️ High Risk
FEI: 3015007456 • Shenzhen, Guangdong • CHINA
FEI Number
3015007456
Location
Shenzhen, Guangdong
Country
CHINAAddress
904,9F,Guangming Tianan Cloud Park Building,255 Zhenmei Road,Zhenmei Community,Xinhu Street,, Guangming 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).
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).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/30/2024 | 73DQAOXIMETER | Division of Southeast Imports (DSEI) | |
| 2/6/2024 | 73DQAOXIMETER | Division of Southeast Imports (DSEI) | |
| 1/3/2024 | 73DQAOXIMETER | Division of Southeast Imports (DSEI) | |
| 1/3/2024 | 73DQAOXIMETER | Division of Southeast Imports (DSEI) | |
| 7/20/2022 | 74OCHOXIMETER, INFRARED, SPORTING, AVIATION | Division of Southeast Imports (DSEI) | |
| 7/5/2022 | 77EPNPUMP, NEBULIZER, MANUAL | Division of Southeast Imports (DSEI) | |
| 5/24/2022 | 73DQAOXIMETER | Division of Southeast Imports (DSEI) | |
| 8/13/2021 | 73DQAOXIMETER | Division of Southeast Imports (DSEI) | |
| 2/11/2021 | 73DQAOXIMETER | Division of Southeast Imports (DSEI) | |
| 10/19/2020 | 73CAFNEBULIZER (DIRECT PATIENT INTERFACE) | Division of Southeast Imports (DSEI) | |
| 10/9/2020 | 73DQAOXIMETER | Division of Southeast Imports (DSEI) | |
| 9/18/2020 | 73DQAOXIMETER | Division of Southeast Imports (DSEI) | |
| 9/2/2020 | 85KNGMONITOR, ULTRASONIC, FETAL | Division of Southeast Imports (DSEI) | |
| 8/22/2020 | 74DQECATHETER, OXIMETER, FIBEROPTIC | Division of Southeast Imports (DSEI) | |
| 7/21/2020 | 73DQAOXIMETER | 3280FRNMFGREG | Division of Northern Border Imports (DNBI) |
| 7/21/2020 | 73DQAOXIMETER | 3280FRNMFGREG | Division of Northern Border Imports (DNBI) |
| 7/20/2020 | 73CAFNEBULIZER (DIRECT PATIENT INTERFACE) | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 7/17/2020 | 73DQAOXIMETER | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 7/15/2020 | 73DQAOXIMETER | Division of Southeast Imports (DSEI) | |
| 6/30/2020 | 73DQAOXIMETER | Division of Southeast Imports (DSEI) | |
| 6/25/2020 | 73DQAOXIMETER | Division of Southeast Imports (DSEI) | |
| 6/24/2020 | 74DQECATHETER, OXIMETER, FIBEROPTIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 6/23/2020 | 73DQAOXIMETER | 341REGISTERED | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Shenzhen Imdk Medical Technology Co., Ltd.'s FDA import refusal history?
Shenzhen Imdk Medical Technology Co., Ltd. (FEI: 3015007456) has 23 FDA import refusal record(s) in our database, spanning from 6/23/2020 to 12/30/2024.
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 Imdk Medical Technology Co., Ltd.'s FEI number is 3015007456.
What types of violations has Shenzhen Imdk Medical Technology Co., Ltd. received?
Shenzhen Imdk Medical Technology 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 Shenzhen Imdk Medical Technology Co., Ltd. come from?
All FDA import refusal data for Shenzhen Imdk Medical 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.