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Laerdal Medical (Suzhou) Co., Ltd.

⚠️ Moderate Risk

FEI: 3004993040 • Suzhou, Jiangsu • CHINA

FEI

FEI Number

3004993040

📍

Location

Suzhou, Jiangsu

🇨🇳

Country

CHINA
🏢

Address

Science & Technology Ind. Park, No. 19 Bldg., Huoju Road, Suzhou, Jiangsu, China

Moderate Risk

FDA Import Risk Assessment

27.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
2
Unique Violations
10/22/2012
Latest Refusal
10/22/2012
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

1184×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

3414×

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
10/22/2012
73BTMVENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
118NOT LISTED
341REGISTERED
Division of Northeast Imports (DNEI)
10/22/2012
73BTMVENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
118NOT LISTED
341REGISTERED
Division of Northeast Imports (DNEI)
10/22/2012
73BTMVENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
118NOT LISTED
341REGISTERED
Division of Northeast Imports (DNEI)
10/22/2012
73BTMVENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
118NOT LISTED
341REGISTERED
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Laerdal Medical (Suzhou) Co., Ltd.'s FDA import refusal history?

Laerdal Medical (Suzhou) Co., Ltd. (FEI: 3004993040) has 4 FDA import refusal record(s) in our database, spanning from 10/22/2012 to 10/22/2012.

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. Laerdal Medical (Suzhou) Co., Ltd.'s FEI number is 3004993040.

What types of violations has Laerdal Medical (Suzhou) Co., Ltd. received?

Laerdal Medical (Suzhou) Co., Ltd. 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 Laerdal Medical (Suzhou) Co., Ltd. come from?

All FDA import refusal data for Laerdal Medical (Suzhou) 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.