Rtw Rontgen-Technik Dr. Warrikhoff Kg
⚠️ Moderate Risk
FEI: 1000538815 • Neuenhagen, Brandenburg • GERMANY
FEI Number
1000538815
Location
Neuenhagen, Brandenburg
Country
GERMANYAddress
Hildesheimer Str. 5-9, BEI BERLIN, Neuenhagen, Brandenburg, 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).
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.
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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 |
|---|---|---|---|
| 11/5/2019 | 90IYBTUBE MOUNT, X-RAY, DIAGNOSTIC | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 11/5/2019 | 90IYBTUBE MOUNT, X-RAY, DIAGNOSTIC | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 9/17/2019 | 90ITYASSEMBLY, TUBE HOUSING, X-RAY, DIAGNOSTIC | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 8/30/2019 | 90ITYASSEMBLY, TUBE HOUSING, X-RAY, DIAGNOSTIC | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Rtw Rontgen-Technik Dr. Warrikhoff Kg's FDA import refusal history?
Rtw Rontgen-Technik Dr. Warrikhoff Kg (FEI: 1000538815) has 4 FDA import refusal record(s) in our database, spanning from 8/30/2019 to 11/5/2019.
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. Rtw Rontgen-Technik Dr. Warrikhoff Kg's FEI number is 1000538815.
What types of violations has Rtw Rontgen-Technik Dr. Warrikhoff Kg received?
Rtw Rontgen-Technik Dr. Warrikhoff Kg has been cited for 5 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 Rtw Rontgen-Technik Dr. Warrikhoff Kg come from?
All FDA import refusal data for Rtw Rontgen-Technik Dr. Warrikhoff Kg 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.