Cardicare Company, LTD
⚠️ Moderate Risk
FEI: 3005667208 • Nanjing, Jiangsu • CHINA
FEI Number
3005667208
Location
Nanjing, Jiangsu
Country
CHINAAddress
Gaochun Economy Zone, 27 Huashanlu; Gaochunxian, Nanjing, Jiangsu, 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 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.
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
3905
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/22/2025 | 74DXQCUFF, BLOOD-PRESSURE | Division of Northern Border Imports (DNBI) | |
| 8/16/2024 | 74DXQCUFF, BLOOD-PRESSURE | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 4/24/2024 | 74DXQCUFF, BLOOD-PRESSURE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 3/3/2021 | 74OFECENTRAL VENOUS BLOOD PRESSURE KIT | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 5/13/2020 | 74OFECENTRAL VENOUS BLOOD PRESSURE KIT | 479DV QUALITY | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Cardicare Company, LTD's FDA import refusal history?
Cardicare Company, LTD (FEI: 3005667208) has 5 FDA import refusal record(s) in our database, spanning from 5/13/2020 to 1/22/2025.
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. Cardicare Company, LTD's FEI number is 3005667208.
What types of violations has Cardicare Company, LTD received?
Cardicare Company, 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 Cardicare Company, LTD come from?
All FDA import refusal data for Cardicare Company, 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.