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COVIDIEN MEDICAL PRODUCTS (SHANGHAI

⚠️ Moderate Risk

FEI: 3029844175 • Shanghai, Shanghai • CHINA

FEI

FEI Number

3029844175

📍

Location

Shanghai, Shanghai

🇨🇳

Country

CHINA
🏢

Address

Building # 10, 789 Puxing Road, Minhang; Minxing District, Shanghai, Shanghai, China

Moderate Risk

FDA Import Risk Assessment

27.1
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
9/25/2024
Latest Refusal
9/25/2024
Earliest Refusal

Score Breakdown

Violation Severity
20.0×40%
Refusal Volume
11.2×30%
Recency
73.8×20%
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).

39051×

3905

Refusal History

DateProductViolationsDivision
9/25/2024
80FLLTHERMOMETER, ELECTRONIC, CLINICAL
341REGISTERED
39053905
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is COVIDIEN MEDICAL PRODUCTS (SHANGHAI's FDA import refusal history?

COVIDIEN MEDICAL PRODUCTS (SHANGHAI (FEI: 3029844175) has 1 FDA import refusal record(s) in our database, spanning from 9/25/2024 to 9/25/2024.

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. COVIDIEN MEDICAL PRODUCTS (SHANGHAI's FEI number is 3029844175.

What types of violations has COVIDIEN MEDICAL PRODUCTS (SHANGHAI received?

COVIDIEN MEDICAL PRODUCTS (SHANGHAI has been cited for 2 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 COVIDIEN MEDICAL PRODUCTS (SHANGHAI come from?

All FDA import refusal data for COVIDIEN MEDICAL PRODUCTS (SHANGHAI 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.