ZHUHAI SEESHEEN MEDICAL TECHNOLOGY
⚠️ Moderate Risk
FEI: 3032823062 • Guangdong • HONG KONG
FEI Number
3032823062
Location
Guangdong
Country
HONG KONGAddress
4-8 Fl 1st Bldg No 199shui'An 1st Rd, Xiangzhou Dist, Zhuhai City, Guangdong, , Hong Kong
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).
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).
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.
Refusal History
Frequently Asked Questions
What is ZHUHAI SEESHEEN MEDICAL TECHNOLOGY's FDA import refusal history?
ZHUHAI SEESHEEN MEDICAL TECHNOLOGY (FEI: 3032823062) has 1 FDA import refusal record(s) in our database, spanning from 12/9/2024 to 12/9/2024.
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. ZHUHAI SEESHEEN MEDICAL TECHNOLOGY's FEI number is 3032823062.
What types of violations has ZHUHAI SEESHEEN MEDICAL TECHNOLOGY received?
ZHUHAI SEESHEEN MEDICAL TECHNOLOGY 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 ZHUHAI SEESHEEN MEDICAL TECHNOLOGY come from?
All FDA import refusal data for ZHUHAI SEESHEEN MEDICAL TECHNOLOGY 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.