SAMTECS LTD
✅ Low Risk
FEI: 3017197224 • Kowloon • HONG KONG
FEI Number
3017197224
Location
Kowloon
Country
HONG KONGAddress
1905 Ginza Plaza Say Ye, , Kowloon, , Hong Kong
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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
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 |
|---|---|---|---|
| 11/5/2020 | 73KHAMASK, SCAVENGING | 341REGISTERED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is SAMTECS LTD's FDA import refusal history?
SAMTECS LTD (FEI: 3017197224) has 1 FDA import refusal record(s) in our database, spanning from 11/5/2020 to 11/5/2020.
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. SAMTECS LTD's FEI number is 3017197224.
What types of violations has SAMTECS LTD received?
SAMTECS 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 SAMTECS LTD come from?
All FDA import refusal data for SAMTECS 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.