SUZHOU YAOTENG MEDICAL EQUIP
⚠️ Moderate Risk
FEI: 3016691152 • Suzhou City • CHINA
FEI Number
3016691152
Location
Suzhou City
Country
CHINAAddress
Bldg 8 1258 Jinfeng S R, , Suzhou City, , 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.
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 SUZHOU YAOTENG MEDICAL EQUIP's FDA import refusal history?
SUZHOU YAOTENG MEDICAL EQUIP (FEI: 3016691152) has 1 FDA import refusal record(s) in our database, spanning from 7/27/2020 to 7/27/2020.
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 YAOTENG MEDICAL EQUIP's FEI number is 3016691152.
What types of violations has SUZHOU YAOTENG MEDICAL EQUIP received?
SUZHOU YAOTENG MEDICAL EQUIP 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 SUZHOU YAOTENG MEDICAL EQUIP come from?
All FDA import refusal data for SUZHOU YAOTENG MEDICAL EQUIP 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.