ZHEJIANG PROTECT MEDICAL EQUIPMENT CO. LTD.
⚠️ Moderate Risk
FEI: 3007616048 • Anji, Zhejiang • CHINA
FEI Number
3007616048
Location
Anji, Zhejiang
Country
CHINAAddress
SCIENCE & TECHNOLOGY ZONE, XIAOFENG TOWN, , Anji, 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
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
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).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
Refusal History
Frequently Asked Questions
What is ZHEJIANG PROTECT MEDICAL EQUIPMENT CO. LTD.'s FDA import refusal history?
ZHEJIANG PROTECT MEDICAL EQUIPMENT CO. LTD. (FEI: 3007616048) has 3 FDA import refusal record(s) in our database, spanning from 5/16/2011 to 10/28/2025.
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. ZHEJIANG PROTECT MEDICAL EQUIPMENT CO. LTD.'s FEI number is 3007616048.
What types of violations has ZHEJIANG PROTECT MEDICAL EQUIPMENT CO. LTD. received?
ZHEJIANG PROTECT MEDICAL EQUIPMENT 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 ZHEJIANG PROTECT MEDICAL EQUIPMENT CO. LTD. come from?
All FDA import refusal data for ZHEJIANG PROTECT MEDICAL EQUIPMENT 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.