HENAN GEESION MEDICAL DEVICES CO.,LTD
⚠️ Moderate Risk
FEI: 3014315142 • Zhengzhou, Henan • CHINA
FEI Number
3014315142
Location
Zhengzhou, Henan
Country
CHINAAddress
2 Nd Floor, No. 2009-046 Science And Technology Building, No.73-10 Wenhua Road, Dongfeng Road, Jinshui District, Zhengzhou, Henan, 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
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/26/2025 | 89OMWADHESIVE BACKED THERMAL SKIN PATCHES | 3260NO ENGLISH | Division of Southwest Imports (DSWI) |
| 9/26/2025 | 79KGXTAPE AND BANDAGE, ADHESIVE | 3260NO ENGLISH | Division of Southwest Imports (DSWI) |
| 9/26/2025 | 79KGXTAPE AND BANDAGE, ADHESIVE | 3260NO ENGLISH | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is HENAN GEESION MEDICAL DEVICES CO.,LTD's FDA import refusal history?
HENAN GEESION MEDICAL DEVICES CO.,LTD (FEI: 3014315142) has 3 FDA import refusal record(s) in our database, spanning from 9/26/2025 to 9/26/2025.
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. HENAN GEESION MEDICAL DEVICES CO.,LTD's FEI number is 3014315142.
What types of violations has HENAN GEESION MEDICAL DEVICES CO.,LTD received?
HENAN GEESION MEDICAL DEVICES 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 HENAN GEESION MEDICAL DEVICES CO.,LTD come from?
All FDA import refusal data for HENAN GEESION MEDICAL DEVICES 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.