E-M Medical Treatment And Electron (Suzhou) Co Ltd
⚠️ High Risk
FEI: 3005047957 • Suzhou, Jiangsu • CHINA
FEI
FEI Number
3005047957
📍
Location
Suzhou, Jiangsu
🇨🇳
Country
CHINA🏢
Address
# 18 Chunqiu Road, Huangdaizhen Xiangcheng, Suzhou, Jiangsu, China
High Risk
FDA Import Risk Assessment
59.8
LowModerateHighCritical
This firm has a significant history of FDA import refusals with notable violations.
Statistics
90
Total Refusals
1
Unique Violations
10/26/2015
Latest Refusal
10/22/2014
Earliest Refusal
Score Breakdown
Violation Severity
70.0×40%
Refusal Volume
72.6×30%
Recency
0.0×20%
Frequency
100.0×10%
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
50890×
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 |
|---|---|---|---|
| 10/26/2015 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/22/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/22/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/22/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/22/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/22/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/22/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/22/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/22/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/22/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/22/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/22/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/22/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/22/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 10/22/2014 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is E-M Medical Treatment And Electron (Suzhou) Co Ltd's FDA import refusal history?
E-M Medical Treatment And Electron (Suzhou) Co Ltd (FEI: 3005047957) has 90 FDA import refusal record(s) in our database, spanning from 10/22/2014 to 10/26/2015.
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. E-M Medical Treatment And Electron (Suzhou) Co Ltd's FEI number is 3005047957.
What types of violations has E-M Medical Treatment And Electron (Suzhou) Co Ltd received?
E-M Medical Treatment And Electron (Suzhou) Co Ltd has been cited for 1 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 E-M Medical Treatment And Electron (Suzhou) Co Ltd come from?
All FDA import refusal data for E-M Medical Treatment And Electron (Suzhou) 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.