ENDOMAGNETICS LTD
⚠️ Moderate Risk
FEI: 3021156062 • Cambridge • UNITED KINGDOM
FEI Number
3021156062
Location
Cambridge
Country
UNITED KINGDOMAddress
330 Cambridge Science P, , Cambridge, , United Kingdom
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/16/2024 | 79NEUMARKER, RADIOGRAPHIC, IMPLANTABLE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/16/2024 | 79NEUMARKER, RADIOGRAPHIC, IMPLANTABLE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/16/2024 | 79NEUMARKER, RADIOGRAPHIC, IMPLANTABLE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/16/2024 | 79NEUMARKER, RADIOGRAPHIC, IMPLANTABLE | 341REGISTERED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ENDOMAGNETICS LTD's FDA import refusal history?
ENDOMAGNETICS LTD (FEI: 3021156062) has 4 FDA import refusal record(s) in our database, spanning from 8/16/2024 to 8/16/2024.
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. ENDOMAGNETICS LTD's FEI number is 3021156062.
What types of violations has ENDOMAGNETICS LTD received?
ENDOMAGNETICS LTD has been cited for 1 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 ENDOMAGNETICS LTD come from?
All FDA import refusal data for ENDOMAGNETICS 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.