Curaden AG
⚠️ Moderate Risk
FEI: 3007113231 • Kriens, Luzern • SWITZERLAND
FEI Number
3007113231
Location
Kriens, Luzern
Country
SWITZERLANDAddress
Amlehnstrasse 22, , Kriens, Luzern, Switzerland
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).
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).
COL ADDED
The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/2/2023 | 76EFWTOOTHBRUSH, MANUAL | Division of Southeast Imports (DSEI) | |
| 4/5/2019 | 63RBY05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Division of West Coast Imports (DWCI) | |
| 4/5/2019 | 63RBY05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Division of West Coast Imports (DWCI) | |
| 4/5/2019 | 63RBY05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Division of West Coast Imports (DWCI) | |
| 4/5/2019 | 63RBY05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Division of West Coast Imports (DWCI) | |
| 4/5/2019 | 63RBY05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Division of West Coast Imports (DWCI) | |
| 4/5/2019 | 63RBY05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Division of West Coast Imports (DWCI) | |
| 4/5/2019 | 63RBY05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Division of West Coast Imports (DWCI) | |
| 4/5/2019 | 63RBY05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Division of West Coast Imports (DWCI) | |
| 4/5/2019 | 63RBY05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Division of West Coast Imports (DWCI) | |
| 4/5/2019 | 63RBY05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Division of West Coast Imports (DWCI) | |
| 4/5/2019 | 63RBY05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Division of West Coast Imports (DWCI) | |
| 4/5/2019 | 63RBY05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Division of West Coast Imports (DWCI) | |
| 4/5/2019 | 63RBY05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Division of West Coast Imports (DWCI) | |
| 4/5/2019 | 63RBY05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Division of West Coast Imports (DWCI) | |
| 4/5/2019 | 63RBY05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Division of West Coast Imports (DWCI) | |
| 4/5/2019 | 63RBY05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Division of West Coast Imports (DWCI) | |
| 4/5/2019 | 63RBY05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Division of West Coast Imports (DWCI) | |
| 4/5/2019 | 63RBY05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Division of West Coast Imports (DWCI) | |
| 5/26/2017 | 76EFWTOOTHBRUSH, MANUAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 4/4/2017 | 63RBY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Curaden AG's FDA import refusal history?
Curaden AG (FEI: 3007113231) has 21 FDA import refusal record(s) in our database, spanning from 4/4/2017 to 10/2/2023.
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. Curaden AG's FEI number is 3007113231.
What types of violations has Curaden AG received?
Curaden AG 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 Curaden AG come from?
All FDA import refusal data for Curaden AG 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.