Perlong Medical Equipment Co Ltd
⚠️ Moderate Risk
FEI: 3005553515 • Nanjing • CHINA
FEI Number
3005553515
Location
Nanjing
Country
CHINAAddress
28-1 Dajiaochang Rd, , Nanjing, , 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
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).
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 |
|---|---|---|---|
| 11/8/2007 | 90IZLSYSTEM, X-RAY, MOBILE | Chicago District Office (CHI-DO) | |
| 11/8/2007 | 90IZLSYSTEM, X-RAY, MOBILE | Chicago District Office (CHI-DO) | |
| 11/8/2007 | 90IZJCAMERA, X-RAY, FLUOROGRAPHIC, CINE OR SPOT | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Perlong Medical Equipment Co Ltd's FDA import refusal history?
Perlong Medical Equipment Co Ltd (FEI: 3005553515) has 3 FDA import refusal record(s) in our database, spanning from 11/8/2007 to 11/8/2007.
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. Perlong Medical Equipment Co Ltd's FEI number is 3005553515.
What types of violations has Perlong Medical Equipment Co Ltd received?
Perlong Medical Equipment 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 Perlong Medical Equipment Co Ltd come from?
All FDA import refusal data for Perlong Medical Equipment 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.