Promisemed Hangzhou Meditech Co., Ltd
⚠️ High Risk
FEI: 3010515547 • Hangzhou City, Zhejiang • CHINA
FEI Number
3010515547
Location
Hangzhou City, Zhejiang
Country
CHINAAddress
No. 1388 Cangxing Street,, Cangqian Community, Yuhang District, Hangzhou City, 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.
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/2/2024 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 6/29/2024 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 5/23/2024 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | Division of West Coast Imports (DWCI) | |
| 5/23/2024 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | Division of West Coast Imports (DWCI) | |
| 3/26/2024 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | 479DV QUALITY | Division of West Coast Imports (DWCI) |
| 10/18/2023 | 80FMFSYRINGE, PISTON | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 7/28/2023 | 80FMFSYRINGE, PISTON | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Promisemed Hangzhou Meditech Co., Ltd's FDA import refusal history?
Promisemed Hangzhou Meditech Co., Ltd (FEI: 3010515547) has 7 FDA import refusal record(s) in our database, spanning from 7/28/2023 to 8/2/2024.
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. Promisemed Hangzhou Meditech Co., Ltd's FEI number is 3010515547.
What types of violations has Promisemed Hangzhou Meditech Co., Ltd received?
Promisemed Hangzhou Meditech Co., Ltd has been cited for 3 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 Promisemed Hangzhou Meditech Co., Ltd come from?
All FDA import refusal data for Promisemed Hangzhou Meditech 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.