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Blease Medical Equipment, Ltd.

⚠️ Moderate Risk

FEI: 3002806541 • Chesham, Buckinghamshire • UNITED KINGDOM

FEI

FEI Number

3002806541

📍

Location

Chesham, Buckinghamshire

🇬🇧
🏢

Address

Deansway, , Chesham, Buckinghamshire, United Kingdom

Moderate Risk

FDA Import Risk Assessment

30.0
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
7/19/2004
Latest Refusal
9/16/2003
Earliest Refusal

Score Breakdown

Violation Severity
56.7×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

5082×

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.

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
7/19/2004
73MNSVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
508NO 510(K)
Division of Southeast Imports (DSEI)
9/16/2003
73FLSMONITOR (APNEA DETECTOR), VENTILATORY EFFORT
341REGISTERED
508NO 510(K)
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Blease Medical Equipment, Ltd.'s FDA import refusal history?

Blease Medical Equipment, Ltd. (FEI: 3002806541) has 2 FDA import refusal record(s) in our database, spanning from 9/16/2003 to 7/19/2004.

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. Blease Medical Equipment, Ltd.'s FEI number is 3002806541.

What types of violations has Blease Medical Equipment, Ltd. received?

Blease Medical Equipment, 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 Blease Medical Equipment, Ltd. come from?

All FDA import refusal data for Blease Medical Equipment, 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.