Dreve Otoplastik Gmbh
⚠️ Moderate Risk
FEI: 3003610251 • Unna, North Rhine-Westphalia • GERMANY
FEI Number
3003610251
Location
Unna, North Rhine-Westphalia
Country
GERMANYAddress
Max-Planck-Str. 31, , Unna, North Rhine-Westphalia, 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.
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 |
|---|---|---|---|
| 10/17/2005 | 77LDGKIT, EARMOLD, IMPRESSION | 508NO 510(K) | Chicago District Office (CHI-DO) |
| 3/12/2004 | 79MDAELASTOMER, SILICONE, FOR SCAR MANAGEMENT | San Francisco District Office (SAN-DO) | |
| 12/17/2003 | 79MDAELASTOMER, SILICONE, FOR SCAR MANAGEMENT | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Dreve Otoplastik Gmbh's FDA import refusal history?
Dreve Otoplastik Gmbh (FEI: 3003610251) has 3 FDA import refusal record(s) in our database, spanning from 12/17/2003 to 10/17/2005.
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. Dreve Otoplastik Gmbh's FEI number is 3003610251.
What types of violations has Dreve Otoplastik Gmbh received?
Dreve Otoplastik 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 Dreve Otoplastik Gmbh come from?
All FDA import refusal data for Dreve Otoplastik 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.