ImportRefusal LogoImportRefusal

EDWARDS LIFESCIENCES AG

✅ Low Risk

FEI: 3012111914 • Bajos De Haina, San Cristobal • DOMINICAN REPUBLIC

FEI

FEI Number

3012111914

📍

Location

Bajos De Haina, San Cristobal

🇩🇴
🏢

Address

Parque Industrial de It, , Bajos De Haina, San Cristobal, Dominican Republic

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
12/8/2020
Latest Refusal
12/8/2020
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
12/8/2020
74DPWFLOWMETER, BLOOD, CARDIOVASCULAR
341REGISTERED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is EDWARDS LIFESCIENCES AG's FDA import refusal history?

EDWARDS LIFESCIENCES AG (FEI: 3012111914) has 1 FDA import refusal record(s) in our database, spanning from 12/8/2020 to 12/8/2020.

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. EDWARDS LIFESCIENCES AG's FEI number is 3012111914.

What types of violations has EDWARDS LIFESCIENCES AG received?

EDWARDS LIFESCIENCES AG 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 EDWARDS LIFESCIENCES AG come from?

All FDA import refusal data for EDWARDS LIFESCIENCES AG 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.