Guangdong Ardent Biomed Co., Ltd
⚠️ Moderate Risk
FEI: 3016692904 • Guangzhou, Guangdong • CHINA
FEI Number
3016692904
Location
Guangzhou, Guangdong
Country
CHINAAddress
High-Tech Industrial 4th Floor, Of C1 Building,No.11 Kaiyuan Road Science City; Development District, Guangzhou, 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 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).
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
Frequently Asked Questions
What is Guangdong Ardent Biomed Co., Ltd's FDA import refusal history?
Guangdong Ardent Biomed Co., Ltd (FEI: 3016692904) has 1 FDA import refusal record(s) in our database, spanning from 2/28/2022 to 2/28/2022.
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. Guangdong Ardent Biomed Co., Ltd's FEI number is 3016692904.
What types of violations has Guangdong Ardent Biomed Co., Ltd received?
Guangdong Ardent Biomed Co., Ltd 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 Guangdong Ardent Biomed Co., Ltd come from?
All FDA import refusal data for Guangdong Ardent Biomed 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.