Romidan Ltd.
✅ Low Risk
FEI: 3003518307 • Kiryat Ono • ISRAEL
FEI Number
3003518307
Location
Kiryat Ono
Country
ISRAELAddress
5, Simkha Holtsberg, , Kiryat Ono, , Israel
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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 |
|---|---|---|---|
| 12/27/2002 | 76EAPUNIT, X-RAY, INTRAORAL | 341REGISTERED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Romidan Ltd.'s FDA import refusal history?
Romidan Ltd. (FEI: 3003518307) has 1 FDA import refusal record(s) in our database, spanning from 12/27/2002 to 12/27/2002.
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. Romidan Ltd.'s FEI number is 3003518307.
What types of violations has Romidan Ltd. received?
Romidan 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 Romidan Ltd. come from?
All FDA import refusal data for Romidan 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.