HANGZHOU BRONCUS MEDICAL CO LTD
⚠️ High Risk
FEI: 3014247261 • Hangzhou, Zhejiang • CHINA
FEI Number
3014247261
Location
Hangzhou, Zhejiang
Country
CHINAAddress
Building 2, No.88 Jiangling Road, Xixing Street, Binjiang District Room 105-136 F/1, , Hangzhou, Zhejiang, 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 |
|---|---|---|---|
| 5/1/2025 | 77EOQBRONCHOSCOPE (FLEXIBLE OR RIGID) | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 5/1/2025 | 77EOQBRONCHOSCOPE (FLEXIBLE OR RIGID) | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 5/1/2025 | 79NJUSUTURE, NONABSORBABLE, NITINOL | 508NO 510(K) | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is HANGZHOU BRONCUS MEDICAL CO LTD's FDA import refusal history?
HANGZHOU BRONCUS MEDICAL CO LTD (FEI: 3014247261) has 3 FDA import refusal record(s) in our database, spanning from 5/1/2025 to 5/1/2025.
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. HANGZHOU BRONCUS MEDICAL CO LTD's FEI number is 3014247261.
What types of violations has HANGZHOU BRONCUS MEDICAL CO LTD received?
HANGZHOU BRONCUS MEDICAL 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 HANGZHOU BRONCUS MEDICAL CO LTD come from?
All FDA import refusal data for HANGZHOU BRONCUS MEDICAL 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.