SHANDONG HUAMEI TECHNOLOGY CO.,LTD.
⚠️ High Risk
FEI: 3016170453 • Weifang, Shandong • CHINA
FEI Number
3016170453
Location
Weifang, Shandong
Country
CHINAAddress
588 Changning Street, High-Tech District, Weifang, Shandong, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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.
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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 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 |
|---|---|---|---|
| 3/14/2025 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/26/2022 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Division of Southeast Imports (DSEI) | |
| 8/12/2021 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 8/4/2021 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | 47NON STD | Division of Southeast Imports (DSEI) |
| 3/29/2021 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Division of Southeast Imports (DSEI) | |
| 11/12/2020 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | 476NO REGISTR | Division of Northern Border Imports (DNBI) |
| 9/9/2020 | 79ONFPOWERED LIGHT BASED NON-LASER SURGICAL INSTRUMENT WITH THERMAL EFFECT | 508NO 510(K) | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is SHANDONG HUAMEI TECHNOLOGY CO.,LTD.'s FDA import refusal history?
SHANDONG HUAMEI TECHNOLOGY CO.,LTD. (FEI: 3016170453) has 7 FDA import refusal record(s) in our database, spanning from 9/9/2020 to 3/14/2025.
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. SHANDONG HUAMEI TECHNOLOGY CO.,LTD.'s FEI number is 3016170453.
What types of violations has SHANDONG HUAMEI TECHNOLOGY CO.,LTD. received?
SHANDONG HUAMEI TECHNOLOGY CO.,LTD. has been cited for 6 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 SHANDONG HUAMEI TECHNOLOGY CO.,LTD. come from?
All FDA import refusal data for SHANDONG HUAMEI TECHNOLOGY 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.