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Beijing Aeonmed Co. Ltd

✅ Low Risk

FEI: 3005837454 • Beijing • CHINA

FEI

FEI Number

3005837454

📍

Location

Beijing

🇨🇳

Country

CHINA
🏢

Address

3rd Floor, Building 11b2, , Beijing, , China

Low Risk

FDA Import Risk Assessment

21.9
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

3
Total Refusals
2
Unique Violations
4/4/2012
Latest Refusal
9/11/2006
Earliest Refusal

Score Breakdown

Violation Severity
36.7×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
5.4×10%
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

3412×

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).

1181×

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).

Refusal History

DateProductViolationsDivision
4/4/2012
73BWLAPPARATUS, ELECTRONANESTHESIA
341REGISTERED
Florida District Office (FLA-DO)
2/14/2008
73BSZGAS MACHINE, ANESTHESIA
118NOT LISTED
Florida District Office (FLA-DO)
9/11/2006
80LDQDEVICE, GENERAL MEDICAL
341REGISTERED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Beijing Aeonmed Co. Ltd's FDA import refusal history?

Beijing Aeonmed Co. Ltd (FEI: 3005837454) has 3 FDA import refusal record(s) in our database, spanning from 9/11/2006 to 4/4/2012.

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. Beijing Aeonmed Co. Ltd's FEI number is 3005837454.

What types of violations has Beijing Aeonmed Co. Ltd received?

Beijing Aeonmed 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 Beijing Aeonmed Co. Ltd come from?

All FDA import refusal data for Beijing Aeonmed 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.