WENZHOU JIACHENG MEDICAL DEVICES CO., LTD
✅ Low Risk
FEI: 3016927292 • Wenzhou, Zhejiang • CHINA
FEI Number
3016927292
Location
Wenzhou, Zhejiang
Country
CHINAAddress
No. 2 Binhai Road,16 Zhixin Shishang Small Garden 23 201 West First, Yongxing Street, Longwan District, , Wenzhou, Zhejiang, China
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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/10/2020 | 80NZJRESPIRATOR, N95, HOME USE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is WENZHOU JIACHENG MEDICAL DEVICES CO., LTD's FDA import refusal history?
WENZHOU JIACHENG MEDICAL DEVICES CO., LTD (FEI: 3016927292) has 1 FDA import refusal record(s) in our database, spanning from 9/10/2020 to 9/10/2020.
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. WENZHOU JIACHENG MEDICAL DEVICES CO., LTD's FEI number is 3016927292.
What types of violations has WENZHOU JIACHENG MEDICAL DEVICES CO., LTD received?
WENZHOU JIACHENG MEDICAL DEVICES 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 WENZHOU JIACHENG MEDICAL DEVICES CO., LTD come from?
All FDA import refusal data for WENZHOU JIACHENG MEDICAL DEVICES 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.