Youda Electronics (Shenzhen) Co., Ltd.
⚠️ Moderate Risk
FEI: 3006312358 • Guang Dong • CHINA
FEI Number
3006312358
Location
Guang Dong
Country
CHINAAddress
Xiangxingganzel Industry Zone, Shajing Baoan Area, Shenzhen, Guang Dong, , 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
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).
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.
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 |
|---|---|---|---|
| 11/1/2012 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Cincinnati District Office (CIN-DO) | |
| 4/13/2009 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Minneapolis District Office (MIN-DO) | |
| 4/13/2009 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Minneapolis District Office (MIN-DO) | |
| 1/15/2008 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | Minneapolis District Office (MIN-DO) |
Frequently Asked Questions
What is Youda Electronics (Shenzhen) Co., Ltd.'s FDA import refusal history?
Youda Electronics (Shenzhen) Co., Ltd. (FEI: 3006312358) has 4 FDA import refusal record(s) in our database, spanning from 1/15/2008 to 11/1/2012.
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. Youda Electronics (Shenzhen) Co., Ltd.'s FEI number is 3006312358.
What types of violations has Youda Electronics (Shenzhen) Co., Ltd. received?
Youda Electronics (Shenzhen) Co., Ltd. has been cited for 3 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 Youda Electronics (Shenzhen) Co., Ltd. come from?
All FDA import refusal data for Youda Electronics (Shenzhen) 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.