ENDO GI MEDICAL LT
⚠️ Moderate Risk
FEI: 3016463905 • Nazerath • ISRAEL
FEI Number
3016463905
Location
Nazerath
Country
ISRAELAddress
13 Wad El Chag St, , Nazerath, , Israel
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 |
|---|---|---|---|
| 3/7/2025 | 78FGESTENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | 341REGISTERED | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is ENDO GI MEDICAL LT's FDA import refusal history?
ENDO GI MEDICAL LT (FEI: 3016463905) has 1 FDA import refusal record(s) in our database, spanning from 3/7/2025 to 3/7/2025.
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. ENDO GI MEDICAL LT's FEI number is 3016463905.
What types of violations has ENDO GI MEDICAL LT received?
ENDO GI MEDICAL LT 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 ENDO GI MEDICAL LT come from?
All FDA import refusal data for ENDO GI MEDICAL LT 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.