ImportRefusal LogoImportRefusal

Teamedics (Taishan) Manufacturing Co., Ltd.

⚠️ Moderate Risk

FEI: 3004512437 • Taishan, Guangdong • CHINA

FEI

FEI Number

3004512437

📍

Location

Taishan, Guangdong

🇨🇳

Country

CHINA
🏢

Address

Chao Jing, Bai Shan Town, Taishan, Guangdong, 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
11/19/2007
Latest Refusal
11/19/2007
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

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
11/19/2007
89LYGMASSAGER, THERAPEUTIC, MANUAL
508NO 510(K)
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Teamedics (Taishan) Manufacturing Co., Ltd.'s FDA import refusal history?

Teamedics (Taishan) Manufacturing Co., Ltd. (FEI: 3004512437) has 1 FDA import refusal record(s) in our database, spanning from 11/19/2007 to 11/19/2007.

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. Teamedics (Taishan) Manufacturing Co., Ltd.'s FEI number is 3004512437.

What types of violations has Teamedics (Taishan) Manufacturing Co., Ltd. received?

Teamedics (Taishan) Manufacturing 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 Teamedics (Taishan) Manufacturing Co., Ltd. come from?

All FDA import refusal data for Teamedics (Taishan) Manufacturing 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.