Shenzhen Maysun Technology Co.,Ltd.
⚠️ Moderate Risk
FEI: 3004643560 • Shenzhen • 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/5/2005 | 79FMKSINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/5/2005 | 80MXINONABSORBABLE GAUZE, SURGICAL SPONGE & WOUND DRESSING FOR EXTERNAL USE (WITH A DRUG) | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/5/2005 | 77KCMDROPPER, ENT | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/5/2005 | 80MXINONABSORBABLE GAUZE, SURGICAL SPONGE & WOUND DRESSING FOR EXTERNAL USE (WITH A DRUG) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Shenzhen Maysun Technology Co.,Ltd.'s FDA import refusal history?
Shenzhen Maysun Technology Co.,Ltd. (FEI: 3004643560) has 4 FDA import refusal record(s) in our database, spanning from 3/5/2005 to 3/5/2005.
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 Maysun Technology Co.,Ltd.'s FEI number is 3004643560.
What types of violations has Shenzhen Maysun Technology Co.,Ltd. received?
Shenzhen Maysun Technology Co.,Ltd. has been cited for 2 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 Maysun Technology Co.,Ltd. come from?
All FDA import refusal data for Shenzhen Maysun 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.