SHENZHEN SIKEN 3D DIGITIZING CO., LTD
⚠️ Moderate Risk
FEI: 3007744197 • Shenzhen, Guangdong • CHINA
FEI Number
3007744197
Location
Shenzhen, Guangdong
Country
CHINAAddress
Sub Park, 4/F,Buildinga, Haoye High-Tech Innovatio, 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
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.
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).
DV NAME
The article appears to be a device and its labeling fails to bear the proprietary or established name.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/31/2011 | 89NZFMASSAGER, COSMETIC, STATIC ELECTRICITY-EMITTING | Los Angeles District Office (LOS-DO) | |
| 1/25/2011 | 89NZFMASSAGER, COSMETIC, STATIC ELECTRICITY-EMITTING | Seattle District Office (SEA-DO) | |
| 1/21/2010 | 89NZFMASSAGER, COSMETIC, STATIC ELECTRICITY-EMITTING | Cincinnati District Office (CIN-DO) | |
| 1/21/2010 | 89NZFMASSAGER, COSMETIC, STATIC ELECTRICITY-EMITTING | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is SHENZHEN SIKEN 3D DIGITIZING CO., LTD's FDA import refusal history?
SHENZHEN SIKEN 3D DIGITIZING CO., LTD (FEI: 3007744197) has 4 FDA import refusal record(s) in our database, spanning from 1/21/2010 to 1/31/2011.
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 SIKEN 3D DIGITIZING CO., LTD's FEI number is 3007744197.
What types of violations has SHENZHEN SIKEN 3D DIGITIZING CO., LTD received?
SHENZHEN SIKEN 3D DIGITIZING CO., LTD 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 SIKEN 3D DIGITIZING CO., LTD come from?
All FDA import refusal data for SHENZHEN SIKEN 3D DIGITIZING 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.