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Changzhou Orthmed Medical Instrument Co., Ltd.

✅ Low Risk

FEI: 3005596372 • Changzhou, Jiangsu • CHINA

FEI

FEI Number

3005596372

📍

Location

Changzhou, Jiangsu

🇨🇳

Country

CHINA
🏢

Address

NO. 177 Qinlinglu, Xinbei, Changzhou, Jiangsu, 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
3/17/2010
Latest Refusal
3/17/2010
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
3/17/2010
87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
341REGISTERED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Changzhou Orthmed Medical Instrument Co., Ltd.'s FDA import refusal history?

Changzhou Orthmed Medical Instrument Co., Ltd. (FEI: 3005596372) has 1 FDA import refusal record(s) in our database, spanning from 3/17/2010 to 3/17/2010.

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. Changzhou Orthmed Medical Instrument Co., Ltd.'s FEI number is 3005596372.

What types of violations has Changzhou Orthmed Medical Instrument Co., Ltd. received?

Changzhou Orthmed Medical Instrument Co., Ltd. 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 Changzhou Orthmed Medical Instrument Co., Ltd. come from?

All FDA import refusal data for Changzhou Orthmed Medical Instrument 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.