VIS (Shanghai) Technology Co., Ltd.
⚠️ High Risk
FEI: 3016076077 • Shanghai, Shanghai • CHINA
FEI Number
3016076077
Location
Shanghai, Shanghai
Country
CHINAAddress
Tinglin Town, No. 58 Linsheng Road; Jinshan, Shanghai, Shanghai, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/2/2024 | 79OLPOVER-THE-COUNTER POWERED RED/BLUE LIGHT BASED LASER FOR ACNE | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 5/13/2024 | 79OLPOVER-THE-COUNTER POWERED RED/BLUE LIGHT BASED LASER FOR ACNE | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 5/13/2024 | 79OLPOVER-THE-COUNTER POWERED RED/BLUE LIGHT BASED LASER FOR ACNE | 508NO 510(K) | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is VIS (Shanghai) Technology Co., Ltd.'s FDA import refusal history?
VIS (Shanghai) Technology Co., Ltd. (FEI: 3016076077) has 3 FDA import refusal record(s) in our database, spanning from 5/13/2024 to 12/2/2024.
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. VIS (Shanghai) Technology Co., Ltd.'s FEI number is 3016076077.
What types of violations has VIS (Shanghai) Technology Co., Ltd. received?
VIS (Shanghai) 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 VIS (Shanghai) Technology Co., Ltd. come from?
All FDA import refusal data for VIS (Shanghai) 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.