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Hitachi Medical System (S) Pte Ltd

✅ Low Risk

FEI: 3010143383 • Singapore • SINGAPORE

FEI

FEI Number

3010143383

📍

Location

Singapore

🇸🇬

Country

SINGAPORE
🏢

Address

7 Tampines Grande, #04-01 Hitachi Square, Singapore, , Singapore

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
8/15/2013
Latest Refusal
8/15/2013
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
8/15/2013
90LSYSYSTEM, ULTRASOUND HYPERTHERMIA, CANCER TREATMENT
341REGISTERED
San Juan District Office (SJN-DO)

Frequently Asked Questions

What is Hitachi Medical System (S) Pte Ltd's FDA import refusal history?

Hitachi Medical System (S) Pte Ltd (FEI: 3010143383) has 1 FDA import refusal record(s) in our database, spanning from 8/15/2013 to 8/15/2013.

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. Hitachi Medical System (S) Pte Ltd's FEI number is 3010143383.

What types of violations has Hitachi Medical System (S) Pte Ltd received?

Hitachi Medical System (S) Pte 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 Hitachi Medical System (S) Pte Ltd come from?

All FDA import refusal data for Hitachi Medical System (S) Pte 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.