Artema Medical Ab
✅ Low Risk
FEI: 1000198970 • Sundbyberg, Stockholms Lan • SWEDEN
FEI Number
1000198970
Location
Sundbyberg, Stockholms Lan
Country
SWEDENAddress
Rissneleden 136, , Sundbyberg, Stockholms Lan, Sweden
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/28/2011 | 74MWIMONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Artema Medical Ab's FDA import refusal history?
Artema Medical Ab (FEI: 1000198970) has 1 FDA import refusal record(s) in our database, spanning from 1/28/2011 to 1/28/2011.
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. Artema Medical Ab's FEI number is 1000198970.
What types of violations has Artema Medical Ab received?
Artema Medical 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 Artema Medical Ab come from?
All FDA import refusal data for Artema Medical 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.