Hammarplast Medical Ab
✅ Low Risk
FEI: 3010651494 • Vastra Gotaland Ian • SWEDEN
FEI Number
3010651494
Location
Vastra Gotaland Ian
Country
SWEDENAddress
Kartaasgatan 8, Box 2069lidkoping, , Vastra Gotaland Ian, , 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
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 |
|---|---|---|---|
| 2/6/2015 | 79GAXTOURNIQUET, NONPNEUMATIC | 341REGISTERED | Atlanta District Office (ATL-DO) |
Frequently Asked Questions
What is Hammarplast Medical Ab's FDA import refusal history?
Hammarplast Medical Ab (FEI: 3010651494) has 1 FDA import refusal record(s) in our database, spanning from 2/6/2015 to 2/6/2015.
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. Hammarplast Medical Ab's FEI number is 3010651494.
What types of violations has Hammarplast Medical Ab received?
Hammarplast 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 Hammarplast Medical Ab come from?
All FDA import refusal data for Hammarplast 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.