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BEIJING HANBAIHAN MEDICAL DEVICE

✅ Low Risk

FEI: 3017631400 • Beijing City • CHINA

FEI

FEI Number

3017631400

📍

Location

Beijing City

🇨🇳

Country

CHINA
🏢

Address

Building 18 Campus 6 8t, , Beijing City, , China

Low Risk

FDA Import Risk Assessment

16.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
8/25/2021
Latest Refusal
8/25/2021
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

3411×

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).

Refusal History

DateProductViolationsDivision
8/25/2021
81ORGPLATELET AND PLASMA SEPARATOR FOR BONE GRAFT HANDLING
341REGISTERED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is BEIJING HANBAIHAN MEDICAL DEVICE's FDA import refusal history?

BEIJING HANBAIHAN MEDICAL DEVICE (FEI: 3017631400) has 1 FDA import refusal record(s) in our database, spanning from 8/25/2021 to 8/25/2021.

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. BEIJING HANBAIHAN MEDICAL DEVICE's FEI number is 3017631400.

What types of violations has BEIJING HANBAIHAN MEDICAL DEVICE received?

BEIJING HANBAIHAN MEDICAL DEVICE has been cited for 1 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 HANBAIHAN MEDICAL DEVICE come from?

All FDA import refusal data for BEIJING HANBAIHAN MEDICAL DEVICE 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.