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BNOS MEDITECH, LTD.

✅ Low Risk

FEI: 3013424193 • STEBBING • UNITED KINGDOM

FEI

FEI Number

3013424193

📍

Location

STEBBING

🇬🇧
🏢

Address

MILL LANE, ESSEX, STEBBING, , United Kingdom

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
5/12/2017
Latest Refusal
5/12/2017
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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).

5081×

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.

Refusal History

DateProductViolationsDivision
5/12/2017
73BZTSTETHOSCOPE, ESOPHAGEAL, WITH ELECTRICAL CONDUCTORS
341REGISTERED
508NO 510(K)
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is BNOS MEDITECH, LTD.'s FDA import refusal history?

BNOS MEDITECH, LTD. (FEI: 3013424193) has 1 FDA import refusal record(s) in our database, spanning from 5/12/2017 to 5/12/2017.

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. BNOS MEDITECH, LTD.'s FEI number is 3013424193.

What types of violations has BNOS MEDITECH, LTD. received?

BNOS MEDITECH, 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 BNOS MEDITECH, LTD. come from?

All FDA import refusal data for BNOS MEDITECH, 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.