ImportRefusal LogoImportRefusal

Advanced Technology Laser Co., Ltd.

⚠️ Moderate Risk

FEI: 3007604279 • Shanghai, Shanghai • CHINA

FEI

FEI Number

3007604279

📍

Location

Shanghai, Shanghai

🇨🇳

Country

CHINA
🏢

Address

5th Fl, Bldg A2, 920 Jianchuan Road, , Shanghai, Shanghai, China

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
9/22/2021
Latest Refusal
9/22/2021
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

471×

NON STD

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.

Refusal History

DateProductViolationsDivision
9/22/2021
79GEXPOWERED LASER SURGICAL INSTRUMENTS
47NON STD
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Advanced Technology Laser Co., Ltd.'s FDA import refusal history?

Advanced Technology Laser Co., Ltd. (FEI: 3007604279) has 1 FDA import refusal record(s) in our database, spanning from 9/22/2021 to 9/22/2021.

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. Advanced Technology Laser Co., Ltd.'s FEI number is 3007604279.

What types of violations has Advanced Technology Laser Co., Ltd. received?

Advanced Technology Laser 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 Advanced Technology Laser Co., Ltd. come from?

All FDA import refusal data for Advanced Technology Laser 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.