Deltronix Equipamentos Ltda
✅ Low Risk
FEI: 3004707068 • Sao Paulo, Sao Paulo • BRAZIL
FEI Number
3004707068
Location
Sao Paulo, Sao Paulo
Country
BRAZILAddress
Rua Barao de Cotegipe 776 800, , Sao Paulo, Sao Paulo, 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).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/18/2010 | 68XIY20DEVICE/DIAG PROD FOR ANIMAL USED MORE THAN 1 SPECIES | 118NOT LISTED | Florida District Office (FLA-DO) |
| 10/5/2004 | 80MDSSENSOR, GLUCOSE, INVASIVE | 341REGISTERED | Florida District Office (FLA-DO) |
| 10/5/2004 | 80MIOLIGHT, THERAPY, SAD(SEASONAL AFFECTIVE DISORDER) | 341REGISTERED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Deltronix Equipamentos Ltda's FDA import refusal history?
Deltronix Equipamentos Ltda (FEI: 3004707068) has 3 FDA import refusal record(s) in our database, spanning from 10/5/2004 to 2/18/2010.
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. Deltronix Equipamentos Ltda's FEI number is 3004707068.
What types of violations has Deltronix Equipamentos Ltda received?
Deltronix Equipamentos Ltda has been cited for 2 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 Deltronix Equipamentos Ltda come from?
All FDA import refusal data for Deltronix Equipamentos 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.