Duder Com Dist Rep Imp E Exp Mat Med Hospitalar Ltda
✅ Low Risk
FEI: 3005826946 • Salvador, Bahia • BRAZIL
FEI Number
3005826946
Location
Salvador, Bahia
Country
BRAZILAddress
Rua Doutor Augusto Viana 73, , Salvador, Bahia, Brazil
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 |
|---|---|---|---|
| 10/16/2006 | 89ISLJOINT, HIP, EXTERNAL LIMB COMPONENT | 341REGISTERED | Florida District Office (FLA-DO) |
| 10/16/2006 | 87KWDPROSTHESIS, TOE, HEMI-, PHALANGEAL | 341REGISTERED | Florida District Office (FLA-DO) |
| 10/16/2006 | 87HSDPROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED | 341REGISTERED | Florida District Office (FLA-DO) |
| 10/16/2006 | 87KXAPROSTHESIS, HIP, FEMORAL, RESURFACING | 341REGISTERED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Duder Com Dist Rep Imp E Exp Mat Med Hospitalar Ltda's FDA import refusal history?
Duder Com Dist Rep Imp E Exp Mat Med Hospitalar Ltda (FEI: 3005826946) has 4 FDA import refusal record(s) in our database, spanning from 10/16/2006 to 10/16/2006.
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. Duder Com Dist Rep Imp E Exp Mat Med Hospitalar Ltda's FEI number is 3005826946.
What types of violations has Duder Com Dist Rep Imp E Exp Mat Med Hospitalar Ltda received?
Duder Com Dist Rep Imp E Exp Mat Med Hospitalar Ltda 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 Duder Com Dist Rep Imp E Exp Mat Med Hospitalar Ltda come from?
All FDA import refusal data for Duder Com Dist Rep Imp E Exp Mat Med Hospitalar Ltda 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.