Aesculap Fleximed
✅ Low Risk
FEI: 3002653643 • Denzlingen • GERMANY
FEI Number
3002653643
Location
Denzlingen
Country
GERMANYAddress
Rob Bosch St, , Denzlingen, , Germany
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
Frequently Asked Questions
What is Aesculap Fleximed's FDA import refusal history?
Aesculap Fleximed (FEI: 3002653643) has 3 FDA import refusal record(s) in our database, spanning from 10/3/2002 to 5/5/2005.
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. Aesculap Fleximed's FEI number is 3002653643.
What types of violations has Aesculap Fleximed received?
Aesculap Fleximed 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 Aesculap Fleximed come from?
All FDA import refusal data for Aesculap Fleximed 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.