HANGZHOU MEDO IMPORT AND EXPORTCO.,LTD.
⚠️ Moderate Risk
FEI: 3016892439 • Hangzhou, Zhejiang • CHINA
FEI Number
3016892439
Location
Hangzhou, Zhejiang
Country
CHINAAddress
Xixi Valley Business Center D-5, No. 80 Zixia Street; Jiangcun Sub-District, Hangzhou, Zhejiang, 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
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).
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
Frequently Asked Questions
What is HANGZHOU MEDO IMPORT AND EXPORTCO.,LTD.'s FDA import refusal history?
HANGZHOU MEDO IMPORT AND EXPORTCO.,LTD. (FEI: 3016892439) has 1 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 MEDO IMPORT AND EXPORTCO.,LTD.'s FEI number is 3016892439.
What types of violations has HANGZHOU MEDO IMPORT AND EXPORTCO.,LTD. received?
HANGZHOU MEDO IMPORT AND EXPORTCO.,LTD. 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 HANGZHOU MEDO IMPORT AND EXPORTCO.,LTD. come from?
All FDA import refusal data for HANGZHOU MEDO IMPORT AND EXPORTCO.,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.