HEALICOM MEDICAL EQUIPMENT CO.,LTD
⚠️ Moderate Risk
FEI: 3018921396 • Nanjiang • CHINA
FEI Number
3018921396
Location
Nanjiang
Country
CHINAAddress
Rm 1720, C2 Kechuangcheng Bldg, No 30 Yufengzhan Rd, Huatai District, Nanjiang, , 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).
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.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/14/2023 | 79NRJULTRASOUND, SKIN PERMEATION | Division of Southwest Imports (DSWI) | |
| 8/14/2023 | 79NRJULTRASOUND, SKIN PERMEATION | Division of Southwest Imports (DSWI) | |
| 8/14/2023 | 85MFDCANNULA, INTRAUTERINE INSEMINATION | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is HEALICOM MEDICAL EQUIPMENT CO.,LTD's FDA import refusal history?
HEALICOM MEDICAL EQUIPMENT CO.,LTD (FEI: 3018921396) has 3 FDA import refusal record(s) in our database, spanning from 8/14/2023 to 8/14/2023.
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. HEALICOM MEDICAL EQUIPMENT CO.,LTD's FEI number is 3018921396.
What types of violations has HEALICOM MEDICAL EQUIPMENT CO.,LTD received?
HEALICOM MEDICAL EQUIPMENT CO.,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 HEALICOM MEDICAL EQUIPMENT CO.,LTD come from?
All FDA import refusal data for HEALICOM MEDICAL EQUIPMENT 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.