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Koo Medical Equipment (Shanghai) Co., Ltd.

⚠️ Moderate Risk

FEI: 3003413553 • Shanghai • CHINA

FEI

FEI Number

3003413553

📍

Location

Shanghai

🇨🇳

Country

CHINA
🏢

Address

1 Songjiang Industrial Park, Songjiang, Shanghai, , China

Moderate Risk

FDA Import Risk Assessment

29.7
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

3
Total Refusals
2
Unique Violations
3/20/2007
Latest Refusal
3/20/2007
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

3413×

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).

5083×

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

DateProductViolationsDivision
3/20/2007
73NHKRESUSCITATOR, MANUAL, NON SELF-INFLATING
341REGISTERED
508NO 510(K)
Los Angeles District Office (LOS-DO)
3/20/2007
73NHKRESUSCITATOR, MANUAL, NON SELF-INFLATING
341REGISTERED
508NO 510(K)
Los Angeles District Office (LOS-DO)
3/20/2007
73NHKRESUSCITATOR, MANUAL, NON SELF-INFLATING
341REGISTERED
508NO 510(K)
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Koo Medical Equipment (Shanghai) Co., Ltd.'s FDA import refusal history?

Koo Medical Equipment (Shanghai) Co., Ltd. (FEI: 3003413553) has 3 FDA import refusal record(s) in our database, spanning from 3/20/2007 to 3/20/2007.

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. Koo Medical Equipment (Shanghai) Co., Ltd.'s FEI number is 3003413553.

What types of violations has Koo Medical Equipment (Shanghai) Co., Ltd. received?

Koo Medical Equipment (Shanghai) 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 Koo Medical Equipment (Shanghai) Co., Ltd. come from?

All FDA import refusal data for Koo Medical Equipment (Shanghai) 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.