Medical Bio Care Sweden AB
✅ Low Risk
FEI: 3003051985 • Vastra Frolunda, Vastra Gotalands Lan • SWEDEN
FEI Number
3003051985
Location
Vastra Frolunda, Vastra Gotalands Lan
Country
SWEDENAddress
Lona Knapes Gata 5, , Vastra Frolunda, Vastra Gotalands 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 |
|---|---|---|---|
| 8/5/2011 | 79MWYSYSTEM, MICROWAVE, HAIR REMOVAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Medical Bio Care Sweden AB's FDA import refusal history?
Medical Bio Care Sweden AB (FEI: 3003051985) has 1 FDA import refusal record(s) in our database, spanning from 8/5/2011 to 8/5/2011.
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. Medical Bio Care Sweden AB's FEI number is 3003051985.
What types of violations has Medical Bio Care Sweden AB received?
Medical Bio Care Sweden 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 Medical Bio Care Sweden AB come from?
All FDA import refusal data for Medical Bio Care Sweden 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.