Contract Medical International GmbH
⚠️ Moderate Risk
FEI: 3003637635 • Dresden, Saxony • GERMANY
FEI Number
3003637635
Location
Dresden, Saxony
Country
GERMANYAddress
Lauensteiner Str. 37, , Dresden, 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
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 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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/18/2015 | 78KOGENDOSCOPE AND/OR ACCESSORIES | New Orleans District Office (NOL-DO) | |
| 3/18/2014 | 74LITCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL | New Orleans District Office (NOL-DO) | |
| 6/14/2013 | 78MIPDEVICE, FECAL INCONTINENCE, IMPLANTED | New Orleans District Office (NOL-DO) | |
| 8/7/2012 | 74LPBCARDIAC ABLATION PERCUTANEOUS CATHETER | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Contract Medical International GmbH's FDA import refusal history?
Contract Medical International GmbH (FEI: 3003637635) has 4 FDA import refusal record(s) in our database, spanning from 8/7/2012 to 11/18/2015.
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. Contract Medical International GmbH's FEI number is 3003637635.
What types of violations has Contract Medical International GmbH received?
Contract Medical International GmbH has been cited for 3 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 Contract Medical International GmbH come from?
All FDA import refusal data for Contract Medical International 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.