Amann Medical GmbH & Co. KG
✅ Low Risk
FEI: 4324 • Emmingen-Liptingen, Baden-Wurttemberg • GERMANY
FEI Number
4324
Location
Emmingen-Liptingen, Baden-Wurttemberg
Country
GERMANYAddress
Neuhauser Str. 43, , Emmingen-Liptingen, Baden-Wurttemberg, 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
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/31/2013 | 86HNQHOOK, OPHTHALMIC | 341REGISTERED | Philadelphia District Office (PHI-DO) |
| 10/31/2013 | 86HNFSCISSORS, OPHTHALMIC | 341REGISTERED | Philadelphia District Office (PHI-DO) |
| 10/31/2013 | 86HNRFORCEPS, OPHTHALMIC | 341REGISTERED | Philadelphia District Office (PHI-DO) |
| 8/23/2013 | 86HNFSCISSORS, OPHTHALMIC | 341REGISTERED | Philadelphia District Office (PHI-DO) |
| 7/25/2005 | 86HNRFORCEPS, OPHTHALMIC | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Amann Medical GmbH & Co. KG's FDA import refusal history?
Amann Medical GmbH & Co. KG (FEI: 4324) has 5 FDA import refusal record(s) in our database, spanning from 7/25/2005 to 10/31/2013.
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. Amann Medical GmbH & Co. KG's FEI number is 4324.
What types of violations has Amann Medical GmbH & Co. KG received?
Amann Medical GmbH & Co. KG 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 Amann Medical GmbH & Co. KG come from?
All FDA import refusal data for Amann Medical GmbH & Co. KG 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.