Ellex Medical Pty Ltd.
⚠️ Moderate Risk
FEI: 3002806902 • Mawson Lakes, South Australia • AUSTRALIA
FEI Number
3002806902
Location
Mawson Lakes, South Australia
Country
AUSTRALIAAddress
3-4 Second Ave, , Mawson Lakes, South Australia, Australia
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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).
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/2/2022 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Division of Southwest Imports (DSWI) | |
| 8/3/2020 | 86HQFLASER, OPHTHALMIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/9/2019 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | 126FAILS STD | Division of Southeast Imports (DSEI) |
| 8/20/2018 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | Division of West Coast Imports (DWCI) | |
| 1/29/2014 | 86HMGSTAND, INSTRUMENT, OPHTHALMIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/29/2014 | 86HQFLASER, OPHTHALMIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/29/2014 | 86NFFDEVICE, STORAGE, IMAGES, OPHTHALMIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/29/2014 | 86HMGSTAND, INSTRUMENT, OPHTHALMIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/29/2014 | 86HQFLASER, OPHTHALMIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/29/2014 | 86HQFLASER, OPHTHALMIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 11/22/2010 | 86HMGSTAND, INSTRUMENT, OPHTHALMIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 11/22/2010 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | 341REGISTERED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Ellex Medical Pty Ltd.'s FDA import refusal history?
Ellex Medical Pty Ltd. (FEI: 3002806902) has 12 FDA import refusal record(s) in our database, spanning from 11/22/2010 to 6/2/2022.
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. Ellex Medical Pty Ltd.'s FEI number is 3002806902.
What types of violations has Ellex Medical Pty Ltd. received?
Ellex Medical Pty Ltd. has been cited for 4 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 Ellex Medical Pty Ltd. come from?
All FDA import refusal data for Ellex 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.