ZHANGJIAGANG XIEHE MEDICAL APPARATUS & INSTRUMENTS CO., Ltd
✅ Low Risk
FEI: 3006750986 • Zhangjiagang City, Jiangsu Province • CHINA
FEI Number
3006750986
Location
Zhangjiagang City, Jiangsu Province
Country
CHINAAddress
No.7th Middle Xinzha Road, Zhashang Industrial Zone,Yangshe Town, FUQIAN DEVELOPMENT ZONE, Zhangjiagang City, Jiangsu Province, 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).
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).
Refusal History
Frequently Asked Questions
What is ZHANGJIAGANG XIEHE MEDICAL APPARATUS & INSTRUMENTS CO., Ltd's FDA import refusal history?
ZHANGJIAGANG XIEHE MEDICAL APPARATUS & INSTRUMENTS CO., Ltd (FEI: 3006750986) has 2 FDA import refusal record(s) in our database, spanning from 7/11/2012 to 8/9/2017.
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. ZHANGJIAGANG XIEHE MEDICAL APPARATUS & INSTRUMENTS CO., Ltd's FEI number is 3006750986.
What types of violations has ZHANGJIAGANG XIEHE MEDICAL APPARATUS & INSTRUMENTS CO., Ltd received?
ZHANGJIAGANG XIEHE MEDICAL APPARATUS & INSTRUMENTS CO., 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 ZHANGJIAGANG XIEHE MEDICAL APPARATUS & INSTRUMENTS CO., Ltd come from?
All FDA import refusal data for ZHANGJIAGANG XIEHE MEDICAL APPARATUS & INSTRUMENTS 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.