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Ce-Mate Bv

✅ Low Risk

FEI: 3011710411 • Enschede • NETHERLANDS

FEI

FEI Number

3011710411

📍

Location

Enschede

🇳🇱
🏢

Address

De Veldmaat 10 High Tech Factory Gebouw, , Enschede, , Netherlands

Low Risk

FDA Import Risk Assessment

20.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
2
Unique Violations
10/14/2015
Latest Refusal
10/14/2015
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
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

1181×

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).

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
10/14/2015
90IYNSYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
118NOT LISTED
341REGISTERED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Ce-Mate Bv's FDA import refusal history?

Ce-Mate Bv (FEI: 3011710411) has 1 FDA import refusal record(s) in our database, spanning from 10/14/2015 to 10/14/2015.

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. Ce-Mate Bv's FEI number is 3011710411.

What types of violations has Ce-Mate Bv received?

Ce-Mate Bv 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 Ce-Mate Bv come from?

All FDA import refusal data for Ce-Mate Bv 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.