Mtderm Gmbh
✅ Low Risk
FEI: 3010966716 • Berlin, Berlin • GERMANY
FEI Number
3010966716
Location
Berlin, Berlin
Country
GERMANYAddress
37-61 Blohmstrasse, , Berlin, Berlin, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/21/2016 | 79GABNEEDLE, SUTURING, DISPOSABLE | 341REGISTERED | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Mtderm Gmbh's FDA import refusal history?
Mtderm Gmbh (FEI: 3010966716) has 1 FDA import refusal record(s) in our database, spanning from 1/21/2016 to 1/21/2016.
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. Mtderm Gmbh's FEI number is 3010966716.
What types of violations has Mtderm Gmbh received?
Mtderm Gmbh has been cited for 1 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 Mtderm Gmbh come from?
All FDA import refusal data for Mtderm 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.