Suzhou Huanqiu Acupuncture Medical Appliance Co., Ltd.
✅ Low Risk
FEI: 3002808150 • Suzhou City, Jiangsu • CHINA
FEI Number
3002808150
Location
Suzhou City, Jiangsu
Country
CHINAAddress
No. 8 Xiangchengqu, Changxin Industrial Zone, Suzhou City, Jiangsu, 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
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 Suzhou Huanqiu Acupuncture Medical Appliance Co., Ltd.'s FDA import refusal history?
Suzhou Huanqiu Acupuncture Medical Appliance Co., Ltd. (FEI: 3002808150) has 2 FDA import refusal record(s) in our database, spanning from 11/2/2005 to 11/2/2005.
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. Suzhou Huanqiu Acupuncture Medical Appliance Co., Ltd.'s FEI number is 3002808150.
What types of violations has Suzhou Huanqiu Acupuncture Medical Appliance Co., Ltd. received?
Suzhou Huanqiu Acupuncture Medical Appliance 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 Suzhou Huanqiu Acupuncture Medical Appliance Co., Ltd. come from?
All FDA import refusal data for Suzhou Huanqiu Acupuncture Medical Appliance 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.