Breas Medical AB
⚠️ Moderate Risk
FEI: 3003244771 • Molnlycke, Vastra Gotalands Lan • SWEDEN
FEI Number
3003244771
Location
Molnlycke, Vastra Gotalands Lan
Country
SWEDENAddress
Foretagsvagen 1, , Molnlycke, Vastra Gotalands 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).
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.
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 |
|---|---|---|---|
| 1/12/2005 | 87MRYAPPLIANCES AND ACCESSORIES, FIXATION, BONE, ABSORBABLE SINGLE/MULTIPLE COMPONENT | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/10/2005 | 87MRYAPPLIANCES AND ACCESSORIES, FIXATION, BONE, ABSORBABLE SINGLE/MULTIPLE COMPONENT | Division of Southeast Imports (DSEI) | |
| 11/3/2004 | 87MRYAPPLIANCES AND ACCESSORIES, FIXATION, BONE, ABSORBABLE SINGLE/MULTIPLE COMPONENT | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Breas Medical AB's FDA import refusal history?
Breas Medical AB (FEI: 3003244771) has 3 FDA import refusal record(s) in our database, spanning from 11/3/2004 to 1/12/2005.
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. Breas Medical AB's FEI number is 3003244771.
What types of violations has Breas Medical AB received?
Breas Medical AB has been cited for 3 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 Breas Medical AB come from?
All FDA import refusal data for Breas 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.