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Cross Tech Diamond Tools Co., Ltd.

✅ Low Risk

FEI: 3004362293 • Samut Prakarn, Bangkok • THAILAND

FEI

FEI Number

3004362293

📍

Location

Samut Prakarn, Bangkok

🇹🇭

Country

THAILAND
🏢

Address

109/87 MOO 2 TEPARAK ROAD, SAMUTPRAKRAN, Samut Prakarn, Bangkok, Thailand

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
10/8/2010
Latest Refusal
10/8/2010
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
10/8/2010
76EJLBUR, DENTAL
341REGISTERED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Cross Tech Diamond Tools Co., Ltd.'s FDA import refusal history?

Cross Tech Diamond Tools Co., Ltd. (FEI: 3004362293) has 1 FDA import refusal record(s) in our database, spanning from 10/8/2010 to 10/8/2010.

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. Cross Tech Diamond Tools Co., Ltd.'s FEI number is 3004362293.

What types of violations has Cross Tech Diamond Tools Co., Ltd. received?

Cross Tech Diamond Tools Co., 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 Cross Tech Diamond Tools Co., Ltd. come from?

All FDA import refusal data for Cross Tech Diamond Tools 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.