SMTP TECHNOLOGY CO LTD
⚠️ Moderate Risk
FEI: 3038476068 • Beijing • CHINA
FEI Number
3038476068
Location
Beijing
Country
CHINAAddress
Sector B Buil Room 2301, G West Road, Beijing, , 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/1/2025 | 87JDXINSTRUMENT, SURGICAL, SONIC AND ACCESSORY/ATTACHMENT | 341REGISTERED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is SMTP TECHNOLOGY CO LTD's FDA import refusal history?
SMTP TECHNOLOGY CO LTD (FEI: 3038476068) has 1 FDA import refusal record(s) in our database, spanning from 8/1/2025 to 8/1/2025.
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. SMTP TECHNOLOGY CO LTD's FEI number is 3038476068.
What types of violations has SMTP TECHNOLOGY CO LTD received?
SMTP TECHNOLOGY 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 SMTP TECHNOLOGY CO LTD come from?
All FDA import refusal data for SMTP 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.