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Mediwatch Uk Ltd

⚠️ Moderate Risk

FEI: 3006177869 • Rugby, Warwickshire • UNITED KINGDOM

FEI

FEI Number

3006177869

📍

Location

Rugby, Warwickshire

🇬🇧
🏢

Address

Lumonics House, Valley Drive, Rugby, Warwickshire, United Kingdom

Moderate Risk

FDA Import Risk Assessment

38.0
LowModerateHighCritical

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

Statistics

8
Total Refusals
2
Unique Violations
5/27/2013
Latest Refusal
11/12/2010
Earliest Refusal

Score Breakdown

Violation Severity
60.7×40%
Refusal Volume
35.3×30%
Recency
0.0×20%
Frequency
31.5×10%
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

5088×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

1187×

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).

Refusal History

DateProductViolationsDivision
5/27/2013
90IYOSYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
118NOT LISTED
508NO 510(K)
Florida District Office (FLA-DO)
5/27/2013
90IYOSYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
118NOT LISTED
508NO 510(K)
Florida District Office (FLA-DO)
5/27/2013
90IYOSYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
118NOT LISTED
508NO 510(K)
Florida District Office (FLA-DO)
5/27/2013
78FENDEVICE, CYSTOMETRIC, HYDRAULIC
118NOT LISTED
508NO 510(K)
Florida District Office (FLA-DO)
5/27/2013
78FENDEVICE, CYSTOMETRIC, HYDRAULIC
118NOT LISTED
508NO 510(K)
Florida District Office (FLA-DO)
5/27/2013
78FENDEVICE, CYSTOMETRIC, HYDRAULIC
118NOT LISTED
508NO 510(K)
Florida District Office (FLA-DO)
5/27/2013
78FENDEVICE, CYSTOMETRIC, HYDRAULIC
118NOT LISTED
508NO 510(K)
Florida District Office (FLA-DO)
11/12/2010
84GXYELECTRODE, CUTANEOUS
508NO 510(K)
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Mediwatch Uk Ltd's FDA import refusal history?

Mediwatch Uk Ltd (FEI: 3006177869) has 8 FDA import refusal record(s) in our database, spanning from 11/12/2010 to 5/27/2013.

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. Mediwatch Uk Ltd's FEI number is 3006177869.

What types of violations has Mediwatch Uk Ltd received?

Mediwatch Uk 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 Mediwatch Uk Ltd come from?

All FDA import refusal data for Mediwatch Uk 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.