Scibase Ab
⚠️ Moderate Risk
FEI: 3008285458 • Sundbyberg, Stockholms Lan • SWEDEN
FEI Number
3008285458
Location
Sundbyberg, Stockholms Lan
Country
SWEDENAddress
Landsvagen 39, , Sundbyberg, Stockholms Lan, Sweden
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/9/2024 | 79ONVMALIGNANT MELANOMAS, DIAGNOSTIC, ELECTRIC IMPEDANCE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/9/2024 | 79ONVMALIGNANT MELANOMAS, DIAGNOSTIC, ELECTRIC IMPEDANCE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/9/2024 | 79ONVMALIGNANT MELANOMAS, DIAGNOSTIC, ELECTRIC IMPEDANCE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/9/2024 | 79ONVMALIGNANT MELANOMAS, DIAGNOSTIC, ELECTRIC IMPEDANCE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/9/2024 | 79ONVMALIGNANT MELANOMAS, DIAGNOSTIC, ELECTRIC IMPEDANCE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/9/2024 | 79ONVMALIGNANT MELANOMAS, DIAGNOSTIC, ELECTRIC IMPEDANCE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/9/2024 | 79ONVMALIGNANT MELANOMAS, DIAGNOSTIC, ELECTRIC IMPEDANCE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/9/2024 | 79ONVMALIGNANT MELANOMAS, DIAGNOSTIC, ELECTRIC IMPEDANCE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/9/2024 | 79ONVMALIGNANT MELANOMAS, DIAGNOSTIC, ELECTRIC IMPEDANCE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/9/2024 | 79ONVMALIGNANT MELANOMAS, DIAGNOSTIC, ELECTRIC IMPEDANCE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/9/2024 | 79ONVMALIGNANT MELANOMAS, DIAGNOSTIC, ELECTRIC IMPEDANCE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/9/2024 | 79ONVMALIGNANT MELANOMAS, DIAGNOSTIC, ELECTRIC IMPEDANCE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/9/2024 | 79ONVMALIGNANT MELANOMAS, DIAGNOSTIC, ELECTRIC IMPEDANCE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 2/9/2024 | 79ONVMALIGNANT MELANOMAS, DIAGNOSTIC, ELECTRIC IMPEDANCE | 341REGISTERED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Scibase Ab's FDA import refusal history?
Scibase Ab (FEI: 3008285458) has 14 FDA import refusal record(s) in our database, spanning from 2/9/2024 to 2/9/2024.
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. Scibase Ab's FEI number is 3008285458.
What types of violations has Scibase Ab received?
Scibase Ab has been cited for 1 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 Scibase Ab come from?
All FDA import refusal data for Scibase Ab 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.