Dima Diagnostika Gmbh
⚠️ Moderate Risk
FEI: 3007025599 • Gottingen, Lower Saxony • GERMANY
FEI Number
3007025599
Location
Gottingen, Lower Saxony
Country
GERMANYAddress
Robert-Bosch-Breite 23, , Gottingen, Lower Saxony, 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
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 |
|---|---|---|---|
| 10/29/2009 | 75LCXKIT, TEST, PREGNANCY, HCG, OVER THE COUNTER | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 10/29/2009 | 85LHDDEVICE, FERTILITY DIAGNOSTIC, PROCEPTIVE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 10/29/2009 | 75LCXKIT, TEST, PREGNANCY, HCG, OVER THE COUNTER | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 10/29/2009 | 85LHDDEVICE, FERTILITY DIAGNOSTIC, PROCEPTIVE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 9/3/2008 | 88NTRIMMUNOHISTOCHEMICAL REAGENT, ANITBODY (MONOCLONAL OR POLYCLONAL) TO P63 PROTEIN IN NUCLEUS OF PROSTA | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Dima Diagnostika Gmbh's FDA import refusal history?
Dima Diagnostika Gmbh (FEI: 3007025599) has 5 FDA import refusal record(s) in our database, spanning from 9/3/2008 to 10/29/2009.
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. Dima Diagnostika Gmbh's FEI number is 3007025599.
What types of violations has Dima Diagnostika Gmbh received?
Dima Diagnostika 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 Dima Diagnostika Gmbh come from?
All FDA import refusal data for Dima Diagnostika 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.