SHENZHEN COMEN MEDICAL INSTRUMEN
⚠️ Moderate Risk
FEI: 3015254921 • Shenzhen, Guangdong • CHINA
FEI Number
3015254921
Location
Shenzhen, Guangdong
Country
CHINAAddress
Gaoxin South Ring Rd, , Shenzhen, Guangdong, 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
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).
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.
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/30/2020 | 74DRKDC-DEFIBRILLATOR, HIGH ENERGY, (INCLUDING PADDLES) | Division of Southeast Imports (DSEI) | |
| 11/27/2020 | 74MMXDEVICE, PERCUTANEOUS RETRIEVAL | Division of Southeast Imports (DSEI) | |
| 11/27/2020 | 74DPSELECTROCARDIOGRAPH | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is SHENZHEN COMEN MEDICAL INSTRUMEN's FDA import refusal history?
SHENZHEN COMEN MEDICAL INSTRUMEN (FEI: 3015254921) has 3 FDA import refusal record(s) in our database, spanning from 11/27/2020 to 11/30/2020.
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. SHENZHEN COMEN MEDICAL INSTRUMEN's FEI number is 3015254921.
What types of violations has SHENZHEN COMEN MEDICAL INSTRUMEN received?
SHENZHEN COMEN MEDICAL INSTRUMEN 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 SHENZHEN COMEN MEDICAL INSTRUMEN come from?
All FDA import refusal data for SHENZHEN COMEN MEDICAL INSTRUMEN 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.