ShenZhen AiJia Medical Appliances Co., Ltd.
✅ Low Risk
FEI: 3014317363 • Shenzhen, Guangdong • CHINA
FEI Number
3014317363
Location
Shenzhen, Guangdong
Country
CHINAAddress
23 Hulu Road, Bao'An, Langxia Community, Shenzhen, Guangdong, China
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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
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).
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).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/9/2019 | 79OHOFIRST AID KIT WITHOUT DRUG | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 7/9/2019 | 79OHOFIRST AID KIT WITHOUT DRUG | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 6/26/2019 | 80OVRKIT, FIRST AID, TALKING | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 7/27/2018 | 79OHOFIRST AID KIT WITHOUT DRUG | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ShenZhen AiJia Medical Appliances Co., Ltd.'s FDA import refusal history?
ShenZhen AiJia Medical Appliances Co., Ltd. (FEI: 3014317363) has 4 FDA import refusal record(s) in our database, spanning from 7/27/2018 to 7/9/2019.
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 AiJia Medical Appliances Co., Ltd.'s FEI number is 3014317363.
What types of violations has ShenZhen AiJia Medical Appliances Co., Ltd. received?
ShenZhen AiJia Medical Appliances 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 ShenZhen AiJia Medical Appliances Co., Ltd. come from?
All FDA import refusal data for ShenZhen AiJia Medical Appliances 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.