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Societe Commerciale Euro-Taiwanaise

✅ Low Risk

FEI: 3004142507 • Taipei, FN • TAIWAN

FEI

FEI Number

3004142507

📍

Location

Taipei, FN

🇹🇼

Country

TAIWAN
🏢

Address

No.112, Sec.2, 3 Fl.; Chung Shan N. Road, Taipei, FN, Taiwan

Low Risk

FDA Import Risk Assessment

19.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

2
Total Refusals
1
Unique Violations
6/8/2004
Latest Refusal
6/8/2004
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

3412×

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
6/8/2004
80LDQDEVICE, GENERAL MEDICAL
341REGISTERED
Los Angeles District Office (LOS-DO)
6/8/2004
80LDQDEVICE, GENERAL MEDICAL
341REGISTERED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Societe Commerciale Euro-Taiwanaise's FDA import refusal history?

Societe Commerciale Euro-Taiwanaise (FEI: 3004142507) has 2 FDA import refusal record(s) in our database, spanning from 6/8/2004 to 6/8/2004.

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. Societe Commerciale Euro-Taiwanaise's FEI number is 3004142507.

What types of violations has Societe Commerciale Euro-Taiwanaise received?

Societe Commerciale Euro-Taiwanaise 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 Societe Commerciale Euro-Taiwanaise come from?

All FDA import refusal data for Societe Commerciale Euro-Taiwanaise 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.