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SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION

⚠️ Moderate Risk

FEI: 3002808139 • Kyoto, Kyoto • JAPAN

FEI

FEI Number

3002808139

📍

Location

Kyoto, Kyoto

🇯🇵

Country

JAPAN
🏢

Address

Nishinokyo Kuwabara -Cho, Nakagyo-Ku; 1, Kyoto, Kyoto, Japan

Moderate Risk

FDA Import Risk Assessment

32.9
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
11/10/2021
Latest Refusal
11/10/2021
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
2.6×20%
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

5081×

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
11/10/2021
83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
508NO 510(K)
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION's FDA import refusal history?

SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION (FEI: 3002808139) has 1 FDA import refusal record(s) in our database, spanning from 11/10/2021 to 11/10/2021.

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. SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION's FEI number is 3002808139.

What types of violations has SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION received?

SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION 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 SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION come from?

All FDA import refusal data for SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION 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.