Shenzhen Comen Medical Instruments Co. Ltd
⚠️ Moderate Risk
FEI: 3008716327 • Shenzhen, Guangdong • CHINA
FEI Number
3008716327
Location
Shenzhen, Guangdong
Country
CHINAAddress
Bldg 2 Floor 1 - 5, Nanhuan Avenue, Matian Subdistrict; Guangming District, 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.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/21/2023 | 73BWLAPPARATUS, ELECTRONANESTHESIA | Division of Southeast Imports (DSEI) | |
| 2/21/2023 | 74DPSELECTROCARDIOGRAPH | Division of Southeast Imports (DSEI) | |
| 2/21/2023 | 80KMIMONITOR, BED PATIENT | Division of Southeast Imports (DSEI) | |
| 2/21/2023 | 74MKJAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) | Division of Southeast Imports (DSEI) | |
| 2/21/2023 | 80LBIUNIT, NEONATAL PHOTOTHERAPY | Division of Southeast Imports (DSEI) | |
| 2/21/2023 | 80ONMRADIANT INFANT WARMER CABINET | Division of Southeast Imports (DSEI) | |
| 2/21/2023 | 80FMZINCUBATOR, NEONATAL | Division of Southeast Imports (DSEI) | |
| 9/29/2015 | 80MRZACCESSORIES, PUMP, INFUSION | Cincinnati District Office (CIN-DO) | |
| 1/15/2013 | 89IKNELECTROMYOGRAPH, DIAGNOSTIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 6/21/2011 | 89IKNELECTROMYOGRAPH, DIAGNOSTIC | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Shenzhen Comen Medical Instruments Co. Ltd's FDA import refusal history?
Shenzhen Comen Medical Instruments Co. Ltd (FEI: 3008716327) has 10 FDA import refusal record(s) in our database, spanning from 6/21/2011 to 2/21/2023.
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 Instruments Co. Ltd's FEI number is 3008716327.
What types of violations has Shenzhen Comen Medical Instruments Co. Ltd received?
Shenzhen Comen Medical Instruments Co. Ltd has been cited for 4 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 Instruments Co. Ltd come from?
All FDA import refusal data for Shenzhen Comen Medical Instruments 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.