TRIMBLE ELECTRONIC PRODUCTS (SHANGH
⚠️ Moderate Risk
FEI: 3013736666 • Shanghai 2001 • CHINA
FEI Number
3013736666
Location
Shanghai 2001
Country
CHINAAddress
Wai Gao Qiao Free, 311 Fute Road M; Trade Zone, Shanghai 2001, , 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).
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 |
|---|---|---|---|
| 1/16/2020 | 95RERALIGNMENT LASER PRODUCT, SURVEYING LEVELING, ALIGNMENT LASER PRODUCTS | 476NO REGISTR | Division of Southwest Imports (DSWI) |
| 6/13/2019 | 95RERALIGNMENT LASER PRODUCT, SURVEYING LEVELING, ALIGNMENT LASER PRODUCTS | 476NO REGISTR | Division of Southwest Imports (DSWI) |
| 5/28/2019 | 95RERALIGNMENT LASER PRODUCT, SURVEYING LEVELING, ALIGNMENT LASER PRODUCTS | 341REGISTERED | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is TRIMBLE ELECTRONIC PRODUCTS (SHANGH's FDA import refusal history?
TRIMBLE ELECTRONIC PRODUCTS (SHANGH (FEI: 3013736666) has 3 FDA import refusal record(s) in our database, spanning from 5/28/2019 to 1/16/2020.
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. TRIMBLE ELECTRONIC PRODUCTS (SHANGH's FEI number is 3013736666.
What types of violations has TRIMBLE ELECTRONIC PRODUCTS (SHANGH received?
TRIMBLE ELECTRONIC PRODUCTS (SHANGH has been cited for 2 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 TRIMBLE ELECTRONIC PRODUCTS (SHANGH come from?
All FDA import refusal data for TRIMBLE ELECTRONIC PRODUCTS (SHANGH 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.