SHENZHEN VIATOM TECHNOLOGY CO LT
⚠️ Moderate Risk
FEI: 3017034965 • Shenzhen • CHINA
FEI Number
3017034965
Location
Shenzhen
Country
CHINAAddress
3d Tingwei Park Honglan, , Shenzhen, , 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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/12/2021 | 85HELMONITOR, HEART RATE, FETAL, ULTRASONIC | Division of Southeast Imports (DSEI) | |
| 4/12/2021 | 73DQAOXIMETER | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 4/12/2021 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 4/12/2021 | 74MWIMONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 4/12/2021 | 74MWIMONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 4/12/2021 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 4/12/2021 | 73PGJOXIMETER, WELLNESS | 341REGISTERED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is SHENZHEN VIATOM TECHNOLOGY CO LT's FDA import refusal history?
SHENZHEN VIATOM TECHNOLOGY CO LT (FEI: 3017034965) has 7 FDA import refusal record(s) in our database, spanning from 4/12/2021 to 4/12/2021.
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 VIATOM TECHNOLOGY CO LT's FEI number is 3017034965.
What types of violations has SHENZHEN VIATOM TECHNOLOGY CO LT received?
SHENZHEN VIATOM TECHNOLOGY CO LT has been cited for 2 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 VIATOM TECHNOLOGY CO LT come from?
All FDA import refusal data for SHENZHEN VIATOM TECHNOLOGY CO LT 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.