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KANEKA MEDIX CORPORATION TOKYO OFFICE

⚠️ Moderate Risk

FEI: 3013269082 • Minato, Tokyo • JAPAN

FEI

FEI Number

3013269082

📍

Location

Minato, Tokyo

🇯🇵

Country

JAPAN
🏢

Address

1 Chome 12-32, Akasaka, Minato, Tokyo, Japan

Moderate Risk

FDA Import Risk Assessment

39.5
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
11/6/2023
Latest Refusal
11/6/2023
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
11.2×30%
Recency
55.9×20%
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

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).

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
11/6/2023
74NIVCORONARY COVERED STENT
118NOT LISTED
508NO 510(K)
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is KANEKA MEDIX CORPORATION TOKYO OFFICE's FDA import refusal history?

KANEKA MEDIX CORPORATION TOKYO OFFICE (FEI: 3013269082) has 1 FDA import refusal record(s) in our database, spanning from 11/6/2023 to 11/6/2023.

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. KANEKA MEDIX CORPORATION TOKYO OFFICE's FEI number is 3013269082.

What types of violations has KANEKA MEDIX CORPORATION TOKYO OFFICE received?

KANEKA MEDIX CORPORATION TOKYO OFFICE 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 KANEKA MEDIX CORPORATION TOKYO OFFICE come from?

All FDA import refusal data for KANEKA MEDIX CORPORATION TOKYO OFFICE 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.