Rz Medizintech Gmbh
⚠️ Moderate Risk
FEI: 3004968149 • Tuttlingen, Baden-Wurttemberg • GERMANY
FEI Number
3004968149
Location
Tuttlingen, Baden-Wurttemberg
Country
GERMANYAddress
Unter Haslen 20, , Tuttlingen, Baden-Wurttemberg, 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 |
|---|---|---|---|
| 12/12/2011 | 77LRCINSTRUMENT, ENT MANUAL SURGICAL | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 12/12/2011 | 77JZFTUBE, EAR SUCTION | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 12/12/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 12/12/2011 | 78FHQHOLDER, NEEDLE | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 12/12/2011 | 79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 12/12/2011 | 85HDFSPECULUM, VAGINAL, METAL | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 12/12/2011 | 79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 12/12/2011 | 79JYCCANNULA, EAR | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 12/12/2011 | 77LRCINSTRUMENT, ENT MANUAL SURGICAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 12/12/2011 | 77KAEFORCEPS, ENT | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 12/12/2011 | 77KBZSNARE, TONSIL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 6/22/2011 | 87HRSPLATE, FIXATION, BONE | 118NOT LISTED | Detroit District Office (DET-DO) |
| 10/31/2008 | 78FFLDISLODGER, STONE, BASKET, URETERAL, METAL | Division of Southeast Imports (DSEI) | |
| 10/31/2008 | 78EZNDILATOR, CATHETER, URETERAL | Division of Southeast Imports (DSEI) | |
| 10/14/2008 | 85HIHHYSTEROSCOPE (AND ACCESSORIES) | 341REGISTERED | Florida District Office (FLA-DO) |
| 10/14/2008 | 78FJLRESECTOSCOPE | 341REGISTERED | Florida District Office (FLA-DO) |
| 10/14/2008 | 78FFNCLAMP, NON-ELECTRICAL | 341REGISTERED | Florida District Office (FLA-DO) |
| 10/14/2008 | 79FSTLIGHT, SURGICAL, FIBEROPTIC | 341REGISTERED | Florida District Office (FLA-DO) |
| 10/14/2008 | 78FAJCYSTOSCOPE, DIAGNOSTIC | 341REGISTERED | Florida District Office (FLA-DO) |
| 10/14/2008 | 78FCLFORCEPS, BIOPSY, NON-ELECTRIC | 341REGISTERED | Florida District Office (FLA-DO) |
| 10/14/2008 | 78FBQTROCAR, GASTRO-UROLOGY | 341REGISTERED | Florida District Office (FLA-DO) |
| 10/14/2008 | 78FFLDISLODGER, STONE, BASKET, URETERAL, METAL | 118NOT LISTED | Florida District Office (FLA-DO) |
| 10/14/2008 | 78EZNDILATOR, CATHETER, URETERAL | 118NOT LISTED | Florida District Office (FLA-DO) |
| 1/5/2006 | 78FEOLITHOTRIPTOR, ULTRASONIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/5/2006 | 78FGMPROBE AND DIRECTOR, GASTRO-UROLOGY | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/5/2006 | 78FECOBTURATOR, FOR ENDOSCOPE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/5/2006 | 78FEDSHEATH, FOR ENDOSCOPE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/5/2006 | 78FCLFORCEPS, BIOPSY, NON-ELECTRIC | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/5/2006 | 78FGBURETEROSCOPE | 341REGISTERED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Rz Medizintech Gmbh's FDA import refusal history?
Rz Medizintech Gmbh (FEI: 3004968149) has 29 FDA import refusal record(s) in our database, spanning from 1/5/2006 to 12/12/2011.
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. Rz Medizintech Gmbh's FEI number is 3004968149.
What types of violations has Rz Medizintech Gmbh received?
Rz Medizintech 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 Rz Medizintech Gmbh come from?
All FDA import refusal data for Rz Medizintech 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.