Dimeda Instrumente GmbH
⚠️ Moderate Risk
FEI: 3002806816 • Tuttlingen, Baden-Wurttemberg • GERMANY
FEI Number
3002806816
Location
Tuttlingen, Baden-Wurttemberg
Country
GERMANYAddress
Gansacker 54&58, , Tuttlingen, Baden-Wurttemberg, Germany
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
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 |
|---|---|---|---|
| 11/14/2013 | 87HXKHOLDER, NEEDLE; ORTHOPEDIC | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 11/14/2013 | 87HRRSCISSORS | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 11/14/2013 | 87HXBPROBE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 11/14/2013 | 85HDFSPECULUM, VAGINAL, METAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 11/14/2013 | 79GFABLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 11/14/2013 | 79GAISTRIPPER, VEIN, REUSABLE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 7/29/2009 | 85HGHCANNULA, SUCTION, UTERINE | 508NO 510(K) | Philadelphia District Office (PHI-DO) |
| 7/29/2009 | 74DQRCANNULA, CATHETER | 508NO 510(K) | Philadelphia District Office (PHI-DO) |
| 7/16/2009 | 85HDAFORCEPS, OBSTETRICAL | Cincinnati District Office (CIN-DO) | |
| 11/18/2003 | 85HDXDILATOR, VAGINAL | 508NO 510(K) | Philadelphia District Office (PHI-DO) |
| 11/12/2003 | 85HDAFORCEPS, OBSTETRICAL | 508NO 510(K) | Philadelphia District Office (PHI-DO) |
| 11/12/2003 | 85HDAFORCEPS, OBSTETRICAL | 508NO 510(K) | Philadelphia District Office (PHI-DO) |
| 11/12/2003 | 85HDAFORCEPS, OBSTETRICAL | 508NO 510(K) | Philadelphia District Office (PHI-DO) |
| 10/27/2003 | 85HDAFORCEPS, OBSTETRICAL | 508NO 510(K) | Philadelphia District Office (PHI-DO) |
| 10/27/2003 | 85HDAFORCEPS, OBSTETRICAL | 508NO 510(K) | Philadelphia District Office (PHI-DO) |
| 10/27/2003 | 85HDAFORCEPS, OBSTETRICAL | 508NO 510(K) | Philadelphia District Office (PHI-DO) |
| 10/27/2003 | 85HDAFORCEPS, OBSTETRICAL | 508NO 510(K) | Philadelphia District Office (PHI-DO) |
| 10/14/2003 | 85HDAFORCEPS, OBSTETRICAL | 508NO 510(K) | Philadelphia District Office (PHI-DO) |
| 10/14/2003 | 85HDAFORCEPS, OBSTETRICAL | 508NO 510(K) | Philadelphia District Office (PHI-DO) |
Frequently Asked Questions
What is Dimeda Instrumente GmbH's FDA import refusal history?
Dimeda Instrumente GmbH (FEI: 3002806816) has 19 FDA import refusal record(s) in our database, spanning from 10/14/2003 to 11/14/2013.
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. Dimeda Instrumente GmbH's FEI number is 3002806816.
What types of violations has Dimeda Instrumente GmbH received?
Dimeda Instrumente GmbH 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 Dimeda Instrumente GmbH come from?
All FDA import refusal data for Dimeda Instrumente GmbH 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.