Lucklaser Hangzhou Naku Technology
⚠️ Moderate Risk
FEI: 3011688976 • Hangzhou • CHINA
FEI Number
3011688976
Location
Hangzhou
Country
CHINAAddress
Binjiang District PuYan Xipu Road #1503, , Hangzhou, , 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
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
NO TAG
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product to which is not affixed a certification in the form of a label or tag in conformity with section 534(h).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/15/2015 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | Cincinnati District Office (CIN-DO) | |
| 9/8/2015 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | Cincinnati District Office (CIN-DO) | |
| 9/8/2015 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Lucklaser Hangzhou Naku Technology's FDA import refusal history?
Lucklaser Hangzhou Naku Technology (FEI: 3011688976) has 3 FDA import refusal record(s) in our database, spanning from 9/8/2015 to 10/15/2015.
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. Lucklaser Hangzhou Naku Technology's FEI number is 3011688976.
What types of violations has Lucklaser Hangzhou Naku Technology received?
Lucklaser Hangzhou Naku Technology has been cited for 4 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 Lucklaser Hangzhou Naku Technology come from?
All FDA import refusal data for Lucklaser Hangzhou Naku Technology 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.