Shenzhen Kaiyan Medical Equipment Limited
⚠️ Moderate Risk
FEI: 3011644607 • Shenzhen, Guangdong • CHINA
FEI Number
3011644607
Location
Shenzhen, Guangdong
Country
CHINAAddress
Building#3 and Building#5, 40th of Fuxin Street, Huaide Community Fuyong Town, Baoan 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
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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
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).
3905
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/3/2025 | 79OLPOVER-THE-COUNTER POWERED RED/BLUE LIGHT BASED LASER FOR ACNE | 476NO REGISTR | Division of Southeast Imports (DSEI) |
| 6/3/2025 | 79OLPOVER-THE-COUNTER POWERED RED/BLUE LIGHT BASED LASER FOR ACNE | 476NO REGISTR | Division of Southeast Imports (DSEI) |
| 6/3/2025 | 79OLPOVER-THE-COUNTER POWERED RED/BLUE LIGHT BASED LASER FOR ACNE | 476NO REGISTR | Division of Southeast Imports (DSEI) |
| 6/3/2025 | 79OLPOVER-THE-COUNTER POWERED RED/BLUE LIGHT BASED LASER FOR ACNE | 476NO REGISTR | Division of Southeast Imports (DSEI) |
| 12/18/2024 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 7/21/2023 | 89ILYLAMP, INFRARED, THERAPEUTIC HEATING | Division of Southeast Imports (DSEI) | |
| 10/8/2022 | 79OLPOVER-THE-COUNTER POWERED RED/BLUE LIGHT BASED LASER FOR ACNE | 223FALSE | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Shenzhen Kaiyan Medical Equipment Limited's FDA import refusal history?
Shenzhen Kaiyan Medical Equipment Limited (FEI: 3011644607) has 7 FDA import refusal record(s) in our database, spanning from 10/8/2022 to 6/3/2025.
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. Shenzhen Kaiyan Medical Equipment Limited's FEI number is 3011644607.
What types of violations has Shenzhen Kaiyan Medical Equipment Limited received?
Shenzhen Kaiyan Medical Equipment Limited 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 Kaiyan Medical Equipment Limited come from?
All FDA import refusal data for Shenzhen Kaiyan Medical Equipment Limited 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.