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Atcor Medical Pty Ltd.

✅ Low Risk

FEI: 3003339185 • West Ryde, New South Wales • AUSTRALIA

FEI

FEI Number

3003339185

📍

Location

West Ryde, New South Wales

🇦🇺

Country

AUSTRALIA
🏢

Address

West Ryde, U 11 1059-1063 Victoria Rd, West Ryde, New South Wales, Australia

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
10/25/2001
Latest Refusal
10/25/2001
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
10/25/2001
81LOQDEVICE, GENERAL PURPOSE HEMATOLOGY
341REGISTERED
508NO 510(K)
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Atcor Medical Pty Ltd.'s FDA import refusal history?

Atcor Medical Pty Ltd. (FEI: 3003339185) has 1 FDA import refusal record(s) in our database, spanning from 10/25/2001 to 10/25/2001.

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. Atcor Medical Pty Ltd.'s FEI number is 3003339185.

What types of violations has Atcor Medical Pty Ltd. received?

Atcor Medical Pty 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 Atcor Medical Pty Ltd. come from?

All FDA import refusal data for Atcor Medical Pty 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.