TUTTUNAUER CO LTD
✅ Low Risk
FEI: 3016338294 • Beit Shemesh • ISRAEL
FEI Number
3016338294
Location
Beit Shemesh
Country
ISRAELAddress
Po Box 170, , Beit Shemesh, , 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
Frequently Asked Questions
What is TUTTUNAUER CO LTD's FDA import refusal history?
TUTTUNAUER CO LTD (FEI: 3016338294) has 3 FDA import refusal record(s) in our database, spanning from 2/28/2020 to 2/28/2020.
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. TUTTUNAUER CO LTD's FEI number is 3016338294.
What types of violations has TUTTUNAUER CO LTD received?
TUTTUNAUER CO 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 TUTTUNAUER CO LTD come from?
All FDA import refusal data for TUTTUNAUER CO 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.