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Cardio Control Nv

⚠️ Moderate Risk

FEI: 3002975637 • Delft, Zuid-Holland • NETHERLANDS

FEI

FEI Number

3002975637

📍

Location

Delft, Zuid-Holland

🇳🇱
🏢

Address

Mercuriusweg 1, , Delft, Zuid-Holland, Netherlands

Moderate Risk

FDA Import Risk Assessment

26.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
10/28/2001
Latest Refusal
10/28/2001
Earliest Refusal

Score Breakdown

Violation Severity
55.0×40%
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

1261×

FAILS STD

The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.

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
10/28/2001
74DPSELECTROCARDIOGRAPH
126FAILS STD
341REGISTERED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Cardio Control Nv's FDA import refusal history?

Cardio Control Nv (FEI: 3002975637) has 1 FDA import refusal record(s) in our database, spanning from 10/28/2001 to 10/28/2001.

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. Cardio Control Nv's FEI number is 3002975637.

What types of violations has Cardio Control Nv received?

Cardio Control Nv 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 Cardio Control Nv come from?

All FDA import refusal data for Cardio Control Nv 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.