Reda Instrumente Gmbh
⚠️ Moderate Risk
FEI: 3002807988 • Tuttlingen, Baden-Wurttemberg • GERMANY
FEI Number
3002807988
Location
Tuttlingen, Baden-Wurttemberg
Country
GERMANYAddress
Gansacker 34, , 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
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).
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/24/2024 | 79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 5/27/2013 | 79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL | 118NOT LISTED | Florida District Office (FLA-DO) |
| 2/4/2013 | 79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 12/20/2012 | 79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL | Florida District Office (FLA-DO) | |
| 6/12/2002 | 80LDQDEVICE, GENERAL MEDICAL | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 6/12/2002 | 80LDQDEVICE, GENERAL MEDICAL | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 6/12/2002 | 87HTXRONGEUR | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 5/23/2002 | 79LRQTRACHEOSTOMY AND NASAL SUCTIONING KIT | Philadelphia District Office (PHI-DO) |
Frequently Asked Questions
What is Reda Instrumente Gmbh's FDA import refusal history?
Reda Instrumente Gmbh (FEI: 3002807988) has 8 FDA import refusal record(s) in our database, spanning from 5/23/2002 to 9/24/2024.
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. Reda Instrumente Gmbh's FEI number is 3002807988.
What types of violations has Reda Instrumente Gmbh received?
Reda Instrumente 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 Reda Instrumente Gmbh come from?
All FDA import refusal data for Reda Instrumente 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.