BMT MEDIZINTECHNIK GMBH
✅ Low Risk
FEI: 3003080312 • Tuttlingen, Baden-wurttemberg • GERMANY
FEI Number
3003080312
Location
Tuttlingen, Baden-wurttemberg
Country
GERMANYAddress
Moltkestr. 37/39, , Tuttlingen, Baden-wurttemberg, 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).
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 |
|---|---|---|---|
| 10/15/2018 | 76DZLSCREW, FIXATION, INTRAOSSEOUS | Division of Southeast Imports (DSEI) | |
| 3/27/2008 | 76EMGFORCEPS, TOOTH EXTRACTOR, SURGICAL | 341REGISTERED | Detroit District Office (DET-DO) |
| 3/27/2008 | 76EMJELEVATOR, SURGICAL, DENTAL | 341REGISTERED | Detroit District Office (DET-DO) |
| 3/27/2008 | 76EKICARRIER, AMALGAM, OPERATIVE | 341REGISTERED | Detroit District Office (DET-DO) |
| 3/27/2008 | 76EGNSCISSORS, SURGICAL TISSUE, DENTAL | 341REGISTERED | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is BMT MEDIZINTECHNIK GMBH's FDA import refusal history?
BMT MEDIZINTECHNIK GMBH (FEI: 3003080312) has 5 FDA import refusal record(s) in our database, spanning from 3/27/2008 to 10/15/2018.
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. BMT MEDIZINTECHNIK GMBH's FEI number is 3003080312.
What types of violations has BMT MEDIZINTECHNIK GMBH received?
BMT MEDIZINTECHNIK 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 BMT MEDIZINTECHNIK GMBH come from?
All FDA import refusal data for BMT MEDIZINTECHNIK 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.