Sejoy Electronics & Instruments Co. LTD.
⚠️ Moderate Risk
FEI: 3005395953 • Hangzhou, Zhejiang • CHINA
FEI Number
3005395953
Location
Hangzhou, Zhejiang
Country
CHINAAddress
Area C,Building 2,No.365, Wuzhou Road, HangzhouYuhang Economic Development Zone,Yuhang, , Hangzhou, Zhejiang, 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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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).
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
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.
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/29/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 8/24/2020 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/9/2018 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 8/21/2015 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 3280FRNMFGREG | Los Angeles District Office (LOS-DO) |
| 4/7/2015 | 75LCXKIT, TEST, PREGNANCY, HCG, OVER THE COUNTER | Cincinnati District Office (CIN-DO) | |
| 3/18/2015 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | San Francisco District Office (SAN-DO) | |
| 2/23/2015 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | Detroit District Office (DET-DO) | |
| 9/15/2014 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | Chicago District Office (CHI-DO) | |
| 6/26/2014 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 3260NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 6/26/2014 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 3260NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 6/24/2014 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 16DIRECTIONS | Southwest Import District Office (SWI-DO) |
| 6/24/2014 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 16DIRECTIONS | Southwest Import District Office (SWI-DO) |
| 6/24/2014 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 16DIRECTIONS | Southwest Import District Office (SWI-DO) |
| 4/3/2014 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | New York District Office (NYK-DO) | |
| 12/20/2012 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | Cincinnati District Office (CIN-DO) | |
| 12/20/2012 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | Cincinnati District Office (CIN-DO) | |
| 12/20/2012 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Sejoy Electronics & Instruments Co. LTD.'s FDA import refusal history?
Sejoy Electronics & Instruments Co. LTD. (FEI: 3005395953) has 17 FDA import refusal record(s) in our database, spanning from 12/20/2012 to 10/29/2020.
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. Sejoy Electronics & Instruments Co. LTD.'s FEI number is 3005395953.
What types of violations has Sejoy Electronics & Instruments Co. LTD. received?
Sejoy Electronics & Instruments Co. LTD. has been cited for 8 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 Sejoy Electronics & Instruments Co. LTD. come from?
All FDA import refusal data for Sejoy Electronics & 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.