B. Braun Surgical, S.A.
✅ Low Risk
FEI: 3003639970 • Rubi, Barcelona • SPAIN
FEI Number
3003639970
Location
Rubi, Barcelona
Country
SPAINAddress
Carretera De Terrassa 121, , Rubi, Barcelona, Spain
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
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
Refusal History
Frequently Asked Questions
What is B. Braun Surgical, S.A.'s FDA import refusal history?
B. Braun Surgical, S.A. (FEI: 3003639970) has 2 FDA import refusal record(s) in our database, spanning from 11/14/2001 to 7/10/2012.
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. B. Braun Surgical, S.A.'s FEI number is 3003639970.
What types of violations has B. Braun Surgical, S.A. received?
B. Braun Surgical, S.A. 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 B. Braun Surgical, S.A. come from?
All FDA import refusal data for B. Braun Surgical, S.A. 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.